Quality Systems Engineer Resume Samples
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Quality Systems Engineer Resume Samples
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CB
C Barrows
Conner
Barrows
6543 Hammes Row
Chicago
IL
+1 (555) 682 8807
6543 Hammes Row
Chicago
IL
Phone
p
+1 (555) 682 8807
Experience
Experience
Houston, TX
Quality Systems Engineer
Houston, TX
West-Koepp
Houston, TX
Quality Systems Engineer
- Provide feedback to Test Engineering Manager & workcell manager on cost and cost trends
- Support and provide technical assistance for the APQP Committee as well as in the development and maintenance of Process FMEA's and PPAP documentation
- Assist with the development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
- Work with site process owners to create, manage and analyze quality system metrics critical to measuring and tracking quality objectives
- Assist operating units with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
- Work with corporate, the OTT division and sites to create and drive improvements to QMS processes
- Ensures the addition and management of any local QMS documents in line with the evolution of the Philips Quality Management System
Boston, MA
Quality & Systems Engineer
Boston, MA
Corkery-West
Boston, MA
Quality & Systems Engineer
- Assist the Quality Assurance Manager in coordinating the development and implementation of activities related to Unimotion-Gear’s Quality Management System. Stay current on new quality initiatives and promote best in class benchmarking
- In conjunction with the Quality Assurance team, Engineering and Production, participate in the development and improvement of process FMEA’s and Control Plans
- Lead the team in 5 WHY analysis for any quality issues, and complete all sections of the 8D process
- Work to continuously improve the quality of the product, and reduce scrap using A3 methodology
- Ensure all internal audits are conducted in a timely manner, and that corrective actions are being implemented according to internal procedure
- Ensure the active duties of maintaining ISO/IATF 16949 certification are achieved
- Assist the management team in coordinating the development and implementation of activities related to the Division’s IATF 16949 quality system standards
present
Chicago, IL
Advanced Quality Systems Engineer
Chicago, IL
Bogisich, Sanford and Jacobi
present
Chicago, IL
Advanced Quality Systems Engineer
present
- Ensure AQS process are carried out in all upcoming development projects in all development locations and plants
- Standardization/harmonization of the AQS process and their integration into the JC valid AQS softwares in the PG/Plant
- Controling + reporting of AQS process
- Support FMEA, PFC & CP with interfaces between the customers assembly groups and the suppliers
- Provides front line Risk analysis and Risk management support via FMEA – Quality Chain Work Instructions
- Supports in Safety assessments according to Potential Product Safety Concern Work Instructions
- Provides technical leadership by applying AQS /Advanced Quality Service/ Business Integration processes
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
James Madison University
Bachelor’s Degree in Engineering
Skills
Skills
- Familiar with ISO 9001, Intel QOS+ System Elements or capable to drive Quality Operating System Element Gaps closure
- Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues
- Possess a broad knowledge of functional areas impacted by Quality Systems
- Ability to follow SOPs and maintain quality standards
- Comprehensive knowledge of quality systems and relationship to business
- Strong attention to detail
- Ability to lead team toward operational objectives
- Has experience in writing protocols/validations and has fundamental knowledge of validation principles
- Ability to adjust and prioritize work to meet deadlines
- Ability to serve in leadership roles on projects or assignments
15 Quality Systems Engineer resume templates
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1
Quality Systems Engineer Resume Examples & Samples
- Drive efforts to enhance the Cisco Business Management System to better represent the goal of an unrivaled Customer Experience while maintaining relevance and value to the business
- Employ structured quality & process optimization approaches (Six Sigma, LEAN, QFD, etc) to drive operational excellence and cross-functional systemic change based on audit findings and other process improvement efforts. Work cross-functionally across all Cisco organizations (such as Sales, Marketing, Engineering, CVCM, HR, IT and Services) to drive and enable systemic change management in business policies, processes, and programs. Leverage and promote best practices adoption company-wide
- Perform internal audits across multiple functions and support the external audit process
- Effectively communicate at all levels from Vice President to individual contributors to increase awareness and provide regular updates using voice, video and written means
- Coordinate Business Management System-related activities to ensure consistent practices globally
- Limited travel might be required to support these activities
- BS Degree in a technical, business or related field. MS or MBA preferred
- At least 8 years of strong proven program/project management skills with at least 10 years experiences in a fast paced, high technology environment
- Strong background in cross-functional product development methodologies
- Demonstrated experience in developing and deploying process improvements and best practices across organizational functions with a strong focus on results
- Demonstrated strong presentation, communication, and teamwork skills with an ability to communicate with different audiences (staff to senior executives) and for different purposes (informational to persuasive)
- Demonstrated leadership qualities including executive presence, ability to influence key stakeholders, and ability to execute thru direct extended teams
- Ability to work with several organizations with differing needs and develop and implement an agreed upon solution. Be flexible to take on different roles/responsibilities as needs change
- Demonstrated evidence of excellent leadership skills
- ISO 9001 knowledge required and experience implementing ISO 9001 is highly desired
- TL9000 & ISO 14001 industry experience a plus
- Internal auditing experience a plus
2
V Mware Quality Systems Engineer Resume Examples & Samples
- Collaborate with teams throughout VMware to identify potential quality misses and understand strategies to improve quality for our customers
- Create project plans and coordinate timelines through internal and external development, QA and documentation resources
- Manage projects, and establish, track and analyze project quality
- Effectively influence teams to do the right thing for quality products though the use of sound analysis and data
- Excellent written, verbal, and visual communication skills
- Experience with Software Development Lifecycle and understanding the role of quality within it
- Self motivated, independent, and works well within and across functional teams
3
Quality Systems Engineer / ts Coordinator Resume Examples & Samples
- Work with the engineering group during product planning, design and development phases to assure that both economic and quality reliability goals are established and achieved
- Responsibility to ensure that customer requirements are addressed. Including the selection of
- Bachelors Degree in Engineering or related field preferred; or equivalent combination of education and work experience
- Understanding of the complete quality management system
- TS-16949 Lead Auditor Certificate preferred but not required
- Minimum 5 years of diversified experience in Quality Management Systems/TS-16949 specific. in an automotive manufacturing environment
- Demonstrated oral and written communication skills, as well as, strong organization skills
- Personal computer skills
- Understanding of manufacturing, assembly, sequencing and equipment principles
- Normal amount of sitting
- May be required to lift, push and/or pull 60 pounds
- Average mobility to move around a manufacturing environment
4
Quality Systems Engineer Resume Examples & Samples
- Be a key driver of cGMP practices within the Quality division
- Provide support for the ISO13485 and 21CFR Part 820 Quality Systems
- Maintain and follow up on CAPA, Internal Audit and other Quality Systems as required
- Prepare metrics and reports on Quality System performance and present to Management
- Be a primary contact for other departments providing quality advice / guidance to assure compliance
- Become an active member of the site audit team, preparing for and participating in Corporate, Regulatory, Customer and Internal Audits
- Prepare validation protocols as required
- Provide a quality review on a range of quality documentation including Procedures, Policies, Specifications, Investigations, GMP records and other Quality Management System Documentation as required
- Prepare and maintain documentation in compliance with the appropriate regulatory requirements
- Periodically review quality systems and practices for improved efficiencies and to assure greater compliance
5
Quality Systems Engineer Resume Examples & Samples
- Maintain the Internal Audit System and CMEU acting as the Quality Auditor with a team of Internal Auditors
- Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations
- Detailed knowledge of the Medical Device regulations, guidance and requirements
- Ability to implement and improve a QMS
- Organise and manage site preparation for Regulatory and Corporate Audits
- Manage Audit back rooms for Regulatory and Corporate Audits
- Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times
- Conduct Supplier audits
- Ability to lead and drive assigned Process Improvements essential
- Prepare, implement and analyse key Quality Systems related documentation
- Provide input and support to the Corrective and Preventive Action (CAPA) program
- Provide training on the Quality Manual and other key Quality Systems procedures
- Prepare Management Review presentations as appropriate
- Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner
- Provide inputs to KPI's and Management Review
- Ensure that Code of Conduct is considered in all business matters carried out
- Third Level Qualification in Quality, Science or Engineering
- Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry
- Qualified and experienced Lead Auditor, preferably within the Medical Device Industry
- Strong interpersonal skills with the ability to communicate effectively at all organisational levels
- The ability to challenge thinking/opinion/actions in light of ensuring Quality Systems is adhered to
- High attention to detail in all aspects of the role
- Proven problem-solving skills
- High self-motivation
6
Quality Systems Engineer Resume Examples & Samples
- Leads the site complaint handling program for Class I, II & III IVD products including but not limited to evaluating, monitoring and investigating of customer complaints
- Supports other site Quality Systems activities including but not limited to change control, training and internal audits
- Ensures the quality system activities are in compliance with all applicable FDA quality system regulations as well as ISO 13485 and ISO 9001 in support of ASR, GPR, and IVD Class I, II and III products
- Performs internal and external audits and supplier surveillance
- Identifies and implements improvements to processes, products, systems, and customer related quality issues
- Collaborates across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, find root cause, determine next steps, and create technical reports
- Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site level
- Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
- Site specific software programs (change control notification program, CAPA, etc.)
- Bachelor’s degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience
7
Quality Systems Engineer Capa Resume Examples & Samples
- Leads the site CAPA and change control programs
- Provides training for CAPA, change control, root cause analysis and other investigational tools
- Supports other site Quality Systems activities including but not limited to document control, training and internal audits as required by Quality Manager or Supervisor
- Provides support for customer and Regulatory audits and inspections
- Supports day-to-day site-specific quality needs for various, moderately complex products or product families. Examples include responding to non-routine quality complaints (e.g. performance related failures)
- Identifies and implements improvements to processes, systems, and customer related quality issues
- May provide guidance or direction to other lower-level personnel such as assistance with prioritization and investigations
- Bachelor’s degree in biotech, science or engineering from accredited college/university
- Minimum of 3+ years related experience in Medical Device or Pharmaceutical Industry
- Class II/III IVD complaint handling experience
- Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred and/or MBA is highly desirable
- Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr)
- Experience with Trackwise, Agile, E1/SAP is a plus
- IND-LSG
8
Quality Systems Engineer Resume Examples & Samples
- Provide quality training to instill a quality minded culture
- Lead structured team problem solving efforts (Six-Sigma, 8D, and Corrective/Preventive Action Reports) to resolve internal/external issues
- Actively participate as a member of PROLaunch New Product Development Teams to bring new products to market when required
- Lead change management activities within the facility
- Lead / participate on cost-out teams
- Improve supplier/customer relationship through effective partnering and communication
- Support the training in order to develop technicians or operators as required
- Support the MESH Initiatives and Zero culture
- Support the Eaton Quality Systems as well as EBE, ISO/TS, etc
- Support and/or participate on Continuous Improvement Activities such as: Kaizen, Ideas Programs, cost out and/or demonstrate improvements in goals year over year in our processes or practices aligned to achieve or business goals and/objectives
- Bachelor’s Degree in Technical Field with lean manufacturing experience, preferred
- 3-5 years of experience in the same position preferred
- Expert in lean manufacturing system including training, planning and implementation of tools
- Position requires strong analytical skills and understanding of problem solving tools/methods (six sigma, 8D, QOS and other) and Balanced Scorecard goal setting process
- Understands role of quality and variation reduction in driving operational improvement (minimum of Green Belt in 6Sigma, preferred)
- Understands supplier quality, tools associated with new product development and launch, quality function deployment, quality management systems (QS, TS) and cost of quality
- Understanding of budgets and cost drivers
- Strong communication skills and comfort with facilitating teams/groups and working with all levels in the organization
- Strong computer skills (MS Office, Project, etc)
- Bilingual English-Spanish (100%)
9
Quality Systems Engineer Resume Examples & Samples
- Experience with performing quality systems engineering, test and evaluation, and verification and validation for launch vehicle components
- BS degree in Mechanical Engineering required
- Experience with risk management
- Experience with engineering drawings and engineering design software
- Knowledge of current expendable launch systems
10
Quality Systems Engineer Resume Examples & Samples
- Develop and maintain audit functions (product, process, and operating system) ensuring quality systems and products are consistent with internal documentation, standards, and customer requirements
- Track, report, and promptly escalate Customer Complaint (8D) report status and ensure closure of corrective actions within timing goals
- Gather Quality Management Review materials from cross functional department to timely meet its frequency
- Support Supplier Audit, supplier survey, any supplier relevant activity and ensure closure and completion of SCAR database
- Generate, analyze, and report on the levels of product quality within the assigned manufacturing areas, including Pareto, Statistical Process Control, and Process Capability Studies
- Develop, analyze, and report statistical data, relative to quality systems performance and implementation, ensuring customer expectations are maintained
- Support failure analysis process, ensuring feedback and corrective action communication and implementation is consistent with customer expectations
- Participate in material disposition decisions and review the status of blocked stock materials for the timely implementation of material disposition decisions
- Project management and leadership skills with an ability to collaborate with cross functional departments such as R&D, Product Management, and Process Engineering
- Familiar with ISO 9001, Intel QOS+ System Elements or capable to drive Quality Operating System Element Gaps closure
- Experience with implementing Six Sigma, Statistical Process Controls, FMEA, process audits and other proactive quality management practices
- Microsoft Office and ERP systems skills
11
Body Quality Systems Engineer Resume Examples & Samples
- Minimum of a Bachelor of Science degree in Mechanical or Electrical Engineering or equivalent from an ABET accredited university
- Minimum of 1 year of experience working on body systems in specific body forward lighting, wipers and vision systems, rear lighting systems, exterior trim or functional plastics
- Master's degree in Engineering, Quality, Business or equivalent from an ABET accredited university
- Reactive Shainin Green/Black Belt certification
- Proactive design for Six Sigma (DFSS) Green/Black Belt certification
- Proven problem solving experience leading projects
- Proven ability to deliver in fast paced work environment with minimum assistance
12
Quality Systems Engineer Resume Examples & Samples
- Create and/or validate training curriculum in area of responsibility
- Review and analyze field and manufacturing line component failures, and corrective actions; feedback to engineering; generate pareto and trend charts; drive corrective actions
- Coordinate and generate failure analysis and corrective action reports for component issues
- Review and guide component reliability testing, provide technical assistance in the testing and checking of assigned parts specialized fields such as physical, functional and environmental testing
- Work with quality, production, manufacturing, suppliers and subcontractors to discuss and resolve quality aspects of specialized parts, materials and assemblies
- DPM expectations are clearly communicated to the supply base
- Communicate changes in Jabil DPM expectations on a timely basis
- Provide communication forum for the exchange of ideas and information with the Worldwide plant quality and functional management departments, associated with new quality initiatives (process control tools)
- Organize verbal and written ideas clearly and use an appropriate business style
- Prepare and present customer presentations related to quality improvement initiatives
- Assess communication style of individual team members and adapt own communication style accordingly
- Define, develop and implement Quality Engineering strategies, which contribute to the campus strategic directions
- Provide regular updates to Quality Engineering Manager on the execution of the strategy
- Identify creative ways to reduce cost by streamlining processes and systems (i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems)
- Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value
- Provide feedback to Test Engineering Manager & workcell manager on cost and cost trends
- Review all supplier discrepancies. Coordinate and track the corrective/preventative action effort
- Participate in the vendor survey activities as applicable. Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts
- Interface and provide technical support on component quality issues with the customer as needed
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor
- Comply and follow all procedures within the company security policy
- May perform other duties and responsibilities as assigned
- Three to five years experience
- Experience with integration and implementation of MES processes and tools/systems
- Specific experience with implementation and use of RAD (Real time alerting DPMO software) is highly desirable
- Experience with process mapping/improvement and requirements definition and analysis
- Experience with definition and documentation of business requirements and system specification
- Or an equivalent combination of education, training or experience
13
Advanced Quality Systems Engineer Resume Examples & Samples
- Ensure AQS process are carried out in all upcoming development projects in all development locations and plants
- Standardization/harmonization of the AQS process and their integration into the JC valid AQS softwares in the PG/Plant
- Transfer experience from conducted analyses into all future projects
- Technical Degree (Preferably Quality faculty)
- Min. 1 year experience in Quality
- Experience in Automotive Engineering
- Knowledge of Quality Management
- FMEA methodology and implementation
- Fluency in English language
14
Quality Systems Engineer Resume Examples & Samples
- Accomplish appropriately with the procedures of ISO-9001 updated version that applies
- Support the diffusion of the Policy of Quality in the department
- Internal Auditor
- Coordinate activities in preparation to the internal and external audits of the Quality System
- Manage all the updates of the Documents Control System through the Q pulse
- Coordinate internal and external audits
- Keep the reports updated of 3 Up’s, Warranties, QMs, Weekly Warranty Report, Security Report, daily report, etc
- Control the approbation formats related to the Quality system
- Coordinate the updates of the quality system ISO 9001/EQS to the updated versions
- Coordinate the adequacy and/or creation of the procedures of the Quality System as a result of the improvement
- Five years of experience at least related to quality manufacturing processes
- Professional degree in Engineering (Electronics, Electromechanical, Industrial or related
- Knowledge of blueprint reading, knowledge of the ISO9001 quality system current version, metrology, basic statistical
15
Quality Systems Engineer Resume Examples & Samples
- Represents the Corporation, Division and Quality Department in a professional manner
- Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
- Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required
- Creates and reviews Quality System Documents
- Creates and reviews Product Documents
- Creates and reviews Test Methods
- Creates/reviews Protocols, Process and Product Validations, Stability Protocols
- Provides work direction as required
- Creates and reviews documents required for Design History File
- Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
- Performs Internal or Supplier Quality System Audits
- Ensures compliance to Department and Division procedures
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
- Interfaces with manufacturing facility or other Division Facilities
- Travels as required by the above duties and responsibilities
- Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities
- Strong Data Management and Report Presentation Skills
- Advanced Microsoft Access and Microsoft Excel skills a must
- Ability to create and qualify pivot tables, pivot charts, macros, queries, forms, reports, etc. across applications
- Understands basic applied statistics
- Has fundamental knowledge of validation principles
- Comprehensive understanding of auditing principles; lead auditor experience a plus
- Ability to participate on teams and maintain positive work environment with those teams
- Good communication skills (verbal, written, and presentation)
- Understands Basic Fundamentals of Engineering Principles
- Ability to handle multiple task assignments
- Ability to translate quality requirements into product specifications
- Ability to interpret Regulations, Corporate, Division and Department Procedures
- BS. in Engineering, Engineering Technology, Science a minimum
- American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
- Minimum 5 years of experience with FDA regulated industry including 3+ years on product development programs
16
Quality Systems Engineer Resume Examples & Samples
- Assist the location in preparing for 3rd party quality system registration audits and closing related non-conformances
- Conduct internal quality audits
- Participate in periodic management reviews of the quality operating system
- Provide quality systems related training including internal auditor training
- Assist the location in preparing for customer audits and closing related non-conformances. Respond to and complete customer quality evaluation surveys
- Assist the location in the use and analysis of statistical methods such as control charts, capability studies, problem solving, Pareto Diagrams and other statistical tools for evaluating and reducing process variability
- Support and provide technical assistance for the APQP Committee as well as in the development and maintenance of Process FMEA's and PPAP documentation
- Update the Quality Manual and Quality System Procedures
- Assist the location in maintenance of the supplier quality system
- Bachelors of Science in engineering field from an accredited institution
- Three years manufacturing experience, preferably in aluminum rolling
- Lean Six Sigma Green Belt certification
- Knowledge of statistical analysis programs (e.g. Minitab)
- Must have strong communication skills and ability to communicate with all parties – customers, vendors, colleagues, superiors, etc
- Experience maintaining the Quality (ISO9001 or TS16949) standards for a manufacturing organization
- Experience auditing to the ISO9001 or TS16949 standard
17
Quality Systems Engineer Resume Examples & Samples
- Drive improvements to the quality system that ensures its suitability, adequacy and effectiveness
- Lead customer quality improvement with a focus on specific customers
- Provide day to day and on-call production and process quality support
- Provide operational support related to issue resolution, product quality/risk assessment and product disposition
- Provide management of document control, calibration, corrective and preventative action, non-conforming material and deviation and supplier quality processes. Schedule and conduct internal and external calibrations as needed
- Update quality related test methods using statistical tools, conduct MSE's, DOE's, hypothesis tests, and process capability studies
- Lead new hire quality orientation, support divisional quality and customer satisfaction
- Provide support in customer, supplier and regulatory audits
- Generate and provide quality metrics for management review
- Other duties as deemed necessary
- Facilitate problem solving and statistical control
- Maintain and evaluate GFPT’s corrective action program
18
Quality Systems Engineer Resume Examples & Samples
- Bachelor’s Degree required – degree/major in engineering or science highly preferred
- Minimum 3 years of experience in a FDA regulated industry (medical device or pharmaceutical) is required
- 3 to 5 years of in a quality role required
- Must be able to work independently and prioritize with little supervision
- Experience in Post market regulatory, quality or compliance areas preferred
- Familiarity with basic quality tools and techniques is required
- Analytical and Critical thinking skills are required
- Experience working with CAPAs in a regulated industry environment is required
19
Quality Systems Engineer Resume Examples & Samples
- Manage Quality Systems for Global Electronics
- Responsible for TS 16949, ISO26262 adherence and compliance
- Responsible for successful maintenance of TS Certification
- Coordinate ISO/TS activities in manufacturing locations and other related design centers for Global Electronics
- Conduct VDA Audits at design centers and manufacturing locations for Global Electronics
- Conduct Line Readiness Audits, PMA, and LPA as needed
- Understand and ensure compliance of ZF TRW systems to customer requirements and business needs
- Alignment of PMA, LPA across Global Electronics
- Follow up and closure of any actions, open items involving cross functional teams as needed
- Maintain Lessons Learned Read Across Database
- Assist in problem solving activities across product lines to maintain customer satisfaction
- Certified TS personnel well versed in AIAG, IATF (TS/ISO) requirements
- Knowledge in VDA systems/ Requirements. Certified personnel Preferred
- Experience in establishing and maintaining Quality Systems in Automotive environment
- Knowledge in Shanin or RedX problem Solving techniques. Certified personnel Preferred
- Electronics product knowledge or background preferred
20
Advanced Quality Systems Engineer Resume Examples & Samples
- Ensure Quality Chain (consistency between Design Failure Mode and Effects analysis / Process FMEA / Control Plan) processes are carried out in all upcoming development projects in all development locations and plants
- Standardization/harmonization of the Quality Chain process and its integration into the Adient valid software in the Product Group/Plant
- Facilitation of Quality Chain process activities in the Product Group and plants
- Controling + reporting of Quality Chain process
- Support FMEA, Proces flow chart & Control Plan with interfaces between the customers assembly groups and the suppliers
- Provides front line Risk analysis and Risk management support via FMEA – Quality Chain Work Instructions
- Supports in Safety assessments according to Potential Product Safety Concern Work Instructions
- Provides technical leadership by applying Quality Chain Business Integration processes
- Ensuring effective communication with all management levels
- Technical education (secondary school/ university)
- Experience in Automotive Engineering is an advantage
- Knowledge of FMEA methodology and implementation
21
Quality Systems Engineer Resume Examples & Samples
- Bachelor’s degree in engineering from an accredited university
- Minimum of 5 years’ experience of manufacturing experience
- Minimum of 2 years’ experience with quality documents such as Gage R&R, PPAP’s, FMEA’s, Control Charts, Control Plans, SPC related reports and/and calculations
- Minimum of 2 years’ experience with ISO/AS9100 quality systems
- Minimum of 1 year experience with Internal Quality Systems Auditing
- This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee
22
Quality Systems Engineer Resume Examples & Samples
- Lead the Quality Management System at Philips Oral Health Care
- Ensure that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported
- Take a lead role in the Quality Management Planning activity of changes to ensure compliance, outsourcing and Philips programs
- Provide Leadership in steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration
- Act on required reporting to respective regulatory and notified bodies for such activities as site registrations, device licenses, changes in product types, changes in activities at the site, and changes in personnel
- Manage Philips Quality Management System related deployments and implementations
- Establishes and executes a transition plan for all QMS related activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Philips Quality Management System
- Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the Philips Quality Management System transition
- Ensures the addition and management of any local QMS documents in line with the evolution of the Philips Quality Management System
- Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary
- Managing site CAPA program and leading CAPA Review Board meetings
- Establishes the Philips CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based designed tool for the CAPA system. Work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820
- Ensures proper CAPA planning and schedule meets the requirements of internal policies and external regulations
23
Quality Systems Engineer Resume Examples & Samples
- Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met
- Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including six sigma may be required
- Conducts risk analysis as needed. Conducts internal or external audits as assigned to ensure compliance to company quality system requirements
- Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use
- Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards
- Maintains records to ensure compliance to GMP/ISO requirements
24
Engine Systems Quality Systems Engineer Resume Examples & Samples
- Bachelor of Science degree in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
- 3 years of experience in automotive Engineering, Manufacturing, or Quality
- Master's degree in Engineering, Quality, Business or equivalent from an ABET accredited university (or equivalent)
- 3 or more years of experience working on Engine Systems in specific Fuel Systems, Cooling systems, Exhaust and Air Induction
- Working knowledge of GD&T and tolerance stack-up analysis
- Proven team leadership experience
- Ability to engage and motivate the extended team members
25
Quality Systems Engineer Resume Examples & Samples
- Create & maintain supplier contact database; plan for incorporation of this information into Master Control
- Update supplier profiles for all Class C suppliers (may also include performance assessment of Class C suppliers). Evaluate profiles for A and B suppliers for compliance to procedure
- Conduct standardized performance assessments with new “benchmark” template (assessments) and ensure minimum required information is submitted with the audit file (on-site audits)
- Identify the need for and facilitate completion of memos (or other documentation) to address any existing gaps in the supplier files within the record retention period
- Generate a database for existing/current supplier management documentation; generate electronic copies for backup/file storage; archive/facilitate off-site storage of physical files
- Create and maintain audit management database (audit date, report date, AAP date, CA/PA due dates, completion dates, EV dates, closure date, etc.). Also include documentation of local SMC review and approval
- Facilitate transition of paper-based to electronic-based systems (audit schedules, SCAR log, audit records (notification, agenda, executive summary, detailed summary, AAP, supplier profile, performance assessments, debarment checks, warning letter search, scorecards, memos, etc.)
- Supplier Management Change Requests (Audit Schedule, ASL, SCAR log, etc.)
- Identify linkages between supplier, material, specification, risk analysis; plan for incorporation of this information into Master Control
- Expand report cards to entire ASL, also to include expansion of ASL (Internal Suppliers, non-inventory suppliers, consultants, contractors, etc.)
- Reorganize ASL into three organizational categories – external BMD suppliers; external Shared Services suppliers; internal Bard suppliers. Possibly develop and include a fourth organization for DCO suppliers
- 100% audit of existing JDE vendors to assess services against requirements for supplier management program. Facilitate changes determined to be necessary as a result of the assessment
- Organize physical filing system. Create physical “supplier files” containing items identified as standardize elements – i.e. audit/assessment (with all support documentation), agreements, profiles, scorecards, baseline memo for supplier classification, etc
- Assist with documentation and communication associated with NCs, SCARs, AAPs, objective evidence
- Develop into auditor in training, auditor, and lead auditor functions
- Prepare reports for SMC meetings – Component Quality Rating, Audit Rating, SCAR Rating, Approval Status Rating, MRR updates, Audit updates, SCAR updates, Approval Status updates
- Cross train in other QS responsibilities (R002, CAPA, metrics, etc.)
- Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems
- Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information
- Comprehensive knowledge of quality systems and relationship to business
- Has experience in writing protocols/validations and has fundamental knowledge of validation principles
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi
- Ability to serve in leadership roles on projects or assignments
- Comprehensive understanding of auditing principles and ability to perform as a lead auditor
- Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies
- Broad knowledge of manufacturing processes
- Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience
- Understands Fundamentals of Engineering Principles
- B.S. in Engineering, Engineering Technology, or Science a minimum
- Minimum 5 years of experience with FDA regulated industry including 3 years in QA preferably Supplier Quality
26
Quality Systems Engineer Resume Examples & Samples
- Bachelor's degree in related field required
- A minimum of 6+ years related work experience required
- Ability to lead team toward operational objectives
- Aptitude to contribute to strategic goal-setting for department/business unit
- Engineering experience in product development for medical devices
- Experience and understanding pf IEC 62304, IEC 60601, and IEC 61010
- Experience leading a team in the Design Validation and Verification phases for medical devices
- Lead system-level definition, development, implementation, and launch of software-only and electromechanical and systems to deliver a valuable product to the end customer and meet the needs of multiple stakeholders
- Collaborate with users and other stakeholders to formalize their needs and maintain formal systems for translating and maintaining the corresponding requirements
- Proactively determine and manage other sources of systems requirements (e.g. regulatory standards, risk management processes, relevant industry standards, and business requirements) throughout the system lifecycle, engaging subsystem teams as needed
- Define and manage the technical interfaces between complex surgical systems and future surgical tools
- Lead the system architecture by managing requirements and partitioning of system, including between software (developed in-house and SOUP), hardware, and disposables
- Manage and raise critical issues to resolve conflicts and minimize impact to program (cost, time, financial performance)
- Partition systems into subsystems. Formally translate and manage apportionment of requirements and functionality among subsystems
- Ensure appropriate change control processes and disciplines, ensuring that changes are appropriately reflected throughout system and subsystems
- Allocate and integrate requirements for multiple disciplines (potentially including electronics, web-based and product software, firmware, etc.) while considering future needs for connectivity and upgrades (e.g. field upgrades, communications to other systems)
- Lead and partner closely with all other system and subsystem teams to optimize the output of the system for the customer
- Manage the resolution of cross-functional and cross-subsystem issues, tradeoffs, and risk in accordance with system objectives
- Manage the integration and verification of subsystems in accordance with program requirements and design. Own the validation of the system against customer requirements
27
Quality Systems Engineer Resume Examples & Samples
- 3 years of relevant quality experience
- Previous working experience in the automotive industry as a Quality Engineer
- Mechanical / Industrial engineer or graduate in science, mechanical or chemistry is preferred
- Working experience in the automotive industry as a Quality Engineer, especially handling German automotive customer
- Able to work independently within the team
- Keen interest in data analysis
- Team spirit and social capabilities are important
- Work diligently and accurately with a great sense for detail
- Interested in projects that will support production processes and testing for product development
28
Quality Systems Engineer Resume Examples & Samples
- Lead and provide infrastructure development support to the corporate business operating system
- University degree in engineering or appropriate technical background in the quality management field
- Trained/certified in standards for Quality Management Systems (QMS): ISO/TS16949, VDA 6.1, EAQF, AVSQ, EFQM
- TS16949 Standard
- Application of QMS tools and techniques
- 5 years work experience in the automotive industry and minimum 3 years on quality related activities
29
Quality Systems Engineer Resume Examples & Samples
- Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics discipline from an accredited university
- Minimum of three (3) years’ experience working in a quality systems engineering or quality engineering environment
- Minimum of one (1) year experience working knowledge of International Organization for Standardization (ISO) 9001 standards
- Master’s degree or higher in Engineering, Physics, Chemistry, Biology, Mathematics/Statistics or related discipline from an accredited university
- Minimum of three (3) years of quality systems engineering or quality engineering experience
- Experience leading cross-functional teams and/or projects
- American Society for Quality (ASQ) certification: Quality Engineer (CQE) and/or Manager of Quality/Organizational Excellence (CMQ/OE)
- Experience in the use of statistical tools
- Lean Six Sigma training with proven ability to understand and apply Lean Six Sigma and other quality tools to product, systems and process problems
- Experience in laboratory or product development
- Experience in manufacturing
- Test method development experience
- Excellent communication skills (oral, written and presentation)
- Established decision-making and problem-solving skills
- Self-motivated with proven ability to apply innovative solutions to problems
30
Quality Systems Engineer Resume Examples & Samples
- Update and continuously improve the QMS systems for compliance to current standards and regulations and customer requirements
- Facilitate improvements of the QMS and provide training in the QMS and GMP
- Lead the CAPA process ensuring corrective actions (CAPA) are completed in accordance with ISO requirements (incl. complete and compliant documentation) in a timely manner
- Facilitate efficient and effective processing of CAPA’s and audit non-conformances
- Host and follow up on external audits (Notified Body, Authorities, Customer Audits)
- Act as project manager/representative on implementation of new Quality IT system
- Represent the Roskilde site (Laboratory Products Division) in QMS improvements, and support quality and regulatory audits
- Degree qualified in engineering or a related field from relevant discipline, or the equivalent knowledge and experience from the Life Science industry
- 3-5+ years’ demonstrable competence gained through successful experience from similar role, preferably with Medical Devices
- Working experience with ISO 13485 & ISO 9001. Understanding of MDD, IVDD, US FDA 21 CFR part 820 is desirable
- Solid experience as facilitator and influencer capable of translating and communicating complex information
- Strong critical thinking skills with attention to detail without losing the greater picture
- Organized, structured and decisive with the ability and willingness to work in ambiguous situations
- Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner
- Committed and self-driven with a positive mindset, flexibility and persistence
31
Quality Systems Engineer Resume Examples & Samples
- Serve as a resource and mentor for quality systems processes, requirements and compliance
- Work with the OTT Director, Quality to serve as the primary divisional point of contact in CAPA, Audits, Metrics and Management Review
- Work with site process owners to create, manage and analyze quality system metrics critical to measuring and tracking quality objectives
- Coach staff on facilitation of thorough investigations from inception to closure
- Work with corporate, the OTT division and sites to create and drive improvements to QMS processes
- Assist with internal, external and corporate audits
- Drive harmonization between OTT sites
- Bachelor's degree (at a minimum) in a technical or scientific field
- Quality certifications such as ASQ or Six Sigma certification is preferred
- A minimum of 4 years’ experience working in a quality/compliance environment is required. Experience with cGMP, FDA regulations such as 21CFR820 and ISO series of quality standards such as ISO 13485 is required. Direct experience with FDA and/or Notified Body inspections/audits is required. Excellent organization and time management skills is required. Effective verbal and written skills including the ability to collaborate and communicate effectively with all levels of management are required. Ability to be proactive, self-motivated and prioritize and multi-task in a fast paced environment is required. Strong interpersonal skills, including persuasion, objectivity, assertiveness, and thoroughness is required
32
Quality Systems Engineer Resume Examples & Samples
- Actively stays current with external and internal quality system standards and requirements
- Providing Quality Systems support for the Galway site
- Support QMS integration activity across the Galway site
- Responsible for component complaint management
- Responsible for complaint liasison with customers
- Approvals as defined on Oracle
- Co-ordinate water and product pyrogen testing as per agreed schedules & procedures
- Identifies deficiencies in quality systems and defines systematic corrective actions
- Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards
- Coordinate Deviation process
- Ensure compliance and drive improvements in QS processes
- Assists in the preparation and maintenance of records associated with the management review process
- Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned
33
Engine Systems Quality Systems Engineer Resume Examples & Samples
- Minimum of a Bachelor of Science degree in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
- Minimum of 5 or more years of experience in Automotive Engineering, Manufacturing, or Quality
- Demonstrated ability to lead cross-functional teams
- Experience working on engine systems in specific fuel Systems, cooling systems, exhaust and air induction
- Demonstrated problem solving experience leading projects
- Demonstrated team leadership experience
- Demonstrated ability to engage and motivate the extended team members
- Demonstrated ability to deliver in fast paced work environment with minimum assistance
34
Engine Systems Quality Systems Engineer Resume Examples & Samples
- Bachelor of Science in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
- 1 year of experience in automotive engineering, manufacturing, or quality
- 3+ years of experience working on engine systems in specific fuel systems, cooling systems, exhaust and air induction
35
X-ray Image Quality Systems Engineer Resume Examples & Samples
- Providing domain expertise to serve as the main integrator between the hardware and software functions to deliver the best image quality in product
- Developing methods to quantify subsystem interactions and their effects on image quality
- Perform basic trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution. Conduct experiments and diagnostic tests, as required to draw conclusions
- Demonstrated ability to make recommendations to technical and program leadership to improve the product, process or technology
- Background in Image processing and algorithm configuration optimization for medical X-Ray images
- Master’s or PhD degree in Physics, Electrical Engineering or other closely related fields
- Proficient in using software tools to perform image processing algorithm design, image analysis and simulations
36
Advance Quality Systems Engineer Resume Examples & Samples
- Function as Change Implementation Leader
- Ensure effectivity dates are held for all changes
- Ensure CR/CNs are initiated for Business Team business review and recommendations
- Maintain Dashboards and Management reports for monitoring change status
- Function as member of Task Team for development and launch of Team Center, APS Tool and Sharepoint site
- Function as Advance Quality Engineer for new Valvetrain Program Launches
- Participate in Project Team Meetings for Launch Programs
- Facilitate closure for all open MQRR (Manufacturing Quality Readiness Review) deliverables
- Facilitate closure for all SRV valves and PVM – Product Value Maps
- Maintain Dashboards and Management reports for monitoring nonconformance status of program launch
- Participate in Gate Reviews in the GCDP process
- Supervise Clerical Support and oversee management of Standardized work Updates/releases
- Facilitate timely releases of Standardized Work and minimize the use of PAA process to release standard work documents to the floor
- Ensure proper accounting for any cost incurred when using additional contract personnel for updating/revising/creating standardized work documents and quality systems plant projects
- Familiarity with Manufacturing process
- Knowledge of GM quality systems and requirements
- Demonstrated familiarity with GMS principles
- Red X training with certified competency (any level)
- High level of analytical ability for effective problem solving
- Well-developed oral and written communication skills
- Appropriate interpersonal styles and communication methods to work effectively with business partners to meet mutual goals required
- Knowledge of and ability to effectively use computer software as it pertains to engineering and quality systems
37
Quality Systems Engineer Resume Examples & Samples
- 0 Function:Plans and directs the overall quality systems program for GKN Aerospace – Engine Products East. Identifies, researches, evaluates, and implements new technology projects throughout. Coordinates selected external and internal technology development
- Duties and Responsibilities
- Directs and coordinates ISO and other quality compliance certifications required by customers and government agencies
- Manages the group’s quality resources to reduce defects and improve overall quality measurements
- Investigates and implements quality process improvements throughout the group
- Communicates and corresponds with customers to meet quality specifications and resolve issues, problems, and complaints
- Identifies, evaluates, and assists with the implementation of new manufacturing technology projects with potential applications to one or more locations within the Sermatech Manufacturing Group
- Oversees research on new products, materials, processes, and procedures to enhance and improve business offerings
- Coordinates selected external and internal technology development and assists with the implementation of new technology projects within the group
- Updates and prepares status reports on new technology developments to appropriate management, engineering, production, and sales personnel
- Writes technical documentation as required
- Represents SMG at appropriate technical conferences and makes occasional presentations
- Identifies and solicits research and development funding from external sources
- Chairs the “best practices” meetings within the SMG organization and represents SMG at Teleflex“best practice” programs
- Manages SMG intellectual property issues and works with internal and external legal counsel when necessary
- Prepares project schedules, budgets, and cost benefit analysis
- Organizes and conducts technical training as required
- 0 Education and/or Experience Requirements
38
Quality Systems Engineer, Senior Resume Examples & Samples
- Promotes and executes quality assurance philosophy throughout the organization
- Conducts audits, both internally and externally, including the completion of customer matrices
- Initiates and follows up on both internal and external corrective actions for root cause analysis
- Responsible for creating and revising internal procedures
- Solves problems, troubleshoots, and develops process improvements with other departments, suppliers, and customers as necessary
- Plays an active role on quality management teams within the organization and keeps the management team abreast of significant issues or developments
- Contributes and presents quality metrics during Management Review
- Maintains a working knowledge of government and industry quality assurance codes and standards
- Performs the investigation of Out of Tolerance Conditions (OOT’s) with calibration
- Prepares and presents technical and program information to the management team
- Supports in the implementation of APQP and PPAP
- Contributes to team effort by maintaining a positive outlook
- Complies with all company policies and procedures, including safety requirements
- Other duties as assigned to ensure customer needs are met
- Bachelor’s or Associate’s degree in Quality Engineering or technical field, or the equivalent work related experience
- Certification as a Certified Quality engineer (CQE) or a Quality Auditor (CQA)
- Two (2) years in a Quality Assurance role in a mechanical, manufacturing or aerospace industry
- Working knowledge of AS9100C and root cause corrective action implementation
- Working knowledge of Federal Aviation Administration (FAA) Part 21
39
Quality Systems Engineer Resume Examples & Samples
- Develops and Executes quality audit plans in accordance with with AF, DoD, and commercial best practices, requirements, and policies
- Applies application of modern quality principles and methods including: quality management system standards, producibility, process qualification/ validation, product design requirements flow down to manufacturing process requirements/ documentation, product and process controls, measurement and test, product/ process audits, statistical applications, configuration management, and lean manufacturing
- Assesses, captures, and tracks certification quality engineering status, risks, and risk mitigation plans
- Interfaces with on-site certification representatives to include USAF, Government, New Entrant, FFRDC, and other Government agencies
- Applies company quality assurance requirements to all certification products, reports, and reviews
- Reports to the Quality Engineering Lead on status of quality engineering activities and products
- Other Duties as Assigned
- 8 years of experience with the development and application of quality assurance and engineering fundamentals and best practices applied to complex aerospace subsystems to include
- Execution of QA and mfg audit plans
- Conducting the audits from a quality assurance perspective
- Performing quality risk analysis and identifying and developing mitigation plans
- Participating in PDRs, CDRs, ERBs, and ChERBs with manufacturing support
- BS degree in engineering, math, or physical sciences; will consider less experience in lieu of advanced degrees
- Experience interfacing with computer-based database and schedule tools
- Prior Air Force SMC or AFRL program experience
40
Quality Systems Engineer Resume Examples & Samples
- The position recognizes that accident and injury prevention are equal in importance to production, quality, delivery, recovery and cost control. The incumbent accepts the responsibility to work safely, practicing and promoting safety consciousness through Arconic EHS standards and practices
- Bachelors of Science degree in engineering from an accredited institution
- Experience maintaining the Quality (ISO9001 or TS16949 / IATF 16949) standards for a manufacturing organization
- Experience auditing to the ISO9001 or TS16949 / IATF 16949 standard
41
Quality Systems Engineer Resume Examples & Samples
- Developing professional expertise, applies company policies and procedures to participate in the development, review, and improvement of the facility’s Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other FMCNA facilities
- Utilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO). Maintains validation records and systems to keep ongoing process validations current and applicable to process
- Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate, when appropriate, from current corporate documents
- Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence
- Uses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of negative trend. Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution
- Reviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements
- Participates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test, and that all calibration activities are performed when due
- Participates as a member of the facility’s Audit Team in performing internal and external audits as required
- Assists in providing in-house training (e.g., calibration, validations, batch production and operation of equipment) in conjunction with plant management to operators and other personnel, as assigned
- Participates in product design control activities for new product lines
- Conducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions
- Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises
- Normally receives general work instructions on routine work, detailed instructions on new projects or assignments
- Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action
- Builds productive working relationships
- Assists with various projects as assigned by direct supervisor
- Minimum of 2-5 years of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a Master’s Degree no prior work experience may be necessary
- Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong knowledge of Health Canada GMP’s
- Must have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills. Knowledge of analytical laboratory methodologies is important
- Professional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities
- FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science certifications (i.e. ASQ, CQE, CMQ/OE) desired
- Good verbal and written communication skills to make oral presentations and write technical reports
42
Quality Systems Engineer Resume Examples & Samples
- Lead ongoing daily departmental activities for Hayward CAPA, Management Review, Change Control, Audits and FCA systems
- Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities
- Lead site training for various quality systems; coach and mentor individuals and teams in root cause investigation and Quality System requirements
- Serves as local administrator for electronic quality systems
- Provide metrics for management review meetings and other platforms as needed
- Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills. Support process with timely closure of observations/audit items
- Balance cost, quality, people and delivery objectives to meet plant strategic agenda
- Other duties, tasks or projects as assigned
- Team player with strong interpersonal/management skills
- Excellent problem solving skills, attention to detail, verbal and written communication
- Good project management skills
- Working knowledge of FDA/ISO Regulations, Application of Good Documentation Practices, and Application of Good Manufacturing Practices
- Bachelor’s of Science degree in Engineering
- 1-3 years of experience in Quality, or related field in the medical device industry
- Must be experienced with interpreting quality system regulations. Audit experience is helpful, but not required
- Six Sigma Green Belt desired
43
Quality Systems Engineer Resume Examples & Samples
- Implements and the enforcement of ISO-compliant Quality Control procedures throughout the processes at Metal Coaters
- Responsible for process quality and yield improvement activities on the Coil Coating Line
- Assumes an active role with regard to ISO auditing and compliance activities
- Performs daily analysis, disposition and management of non-compliant (HFI) material(s) diverted from the production process(s)
- Tracks, manages and reports raw materials consumed on the coil coating line. This includes improving/eliminating the consumption of raw materials where possible, to reduce operating cost, without impacting the process or product liabilities of Metal Coaters
- Analyzes process data via SPC methods, to validate or refine the Quality Control standards in place on the production line(s)
- Develops and generates Process Control (KPI) and Product Quality/Performance reports as assigned
- Calibrates and controls all product-measuring devices used by production employees to test and evaluate product at Metal Coaters
- Assists the Quality Technician with reviewing, approving and ensuring the correctness of the process parameters designed into each incoming shop order to Metal Coaters
- Performs all of the functions of the Quality Technician when called upon due to vacation, illness or other reason for absence
- Responsible for understanding and complying with the fundamental principles associated with the Quality and Environmental Managements systems in place at Metal Coaters
- Responsible for communicating daily with all levels of employees in order to assist in resolving problems and achieving company goals
- Keeps equipment and work area clean and orderly
- Ensure compliance with federal and state laws
- Perform all duties in a safe manner
44
Quality Systems Engineer Resume Examples & Samples
- Must possess thorough knowledge & understanding of the ISO9000 and/or AS9100 Quality Management Standards and their application to manufacturing industry
- Demonstrated experience in auditing quality management systems and related operations within the manufacturing environment
- Preferably experience in Lean Six Sigma processes & requirements
- Technical knowledge of quality principles, quality assurance and quality control, process controls, &mechanical inspection techniques
- Works well within the team environment &under pressure
- Strong analytical skills
- Strong priority & time management skills
- Excellent verbal communication & writing skills
- Ability to conduct process reviews and technical data package producibility reviews with suppliers & engineering teams
- Ability to lead, coordinate, facilitate technical quality assurance activities among multiple teams
- Ability to perform quality trend analysis, using failure history/reliability data, & identity key opportunities for improvement
- B.A. Degree, Certification or License in a technical discipline or equivalent experience in the related technical discipline
- Three (3) or more years of related experience and demonstrated ability to perform the essential functions of the job typically required
- ASQ CQA preferred and other applicable certification desired
- Previous or current DMIR license holder is an added asset
45
Quality Systems Engineer Resume Examples & Samples
- Bachelor's Degree from an accredited institution
- Minimum of 3 years of experience working in Quality Engineering role within a manufacturing environment
- Bachelor's Degree in Engineering, Metallurgy, Metallurgical Engineering, Mechanical Engineering, Materials Engineering, or Material Science from an accredited institution
- 5+ years relevant work experience
- Experience in the Aerospace manufacturing
- Strong working knowledge and experience working with Quality systems and specifications
- AS9100 specification experience is desired
46
Quality Systems Engineer Resume Examples & Samples
- Use and maintenance of the ETQ Document Control module to maintain procedures
- Be the Stafford Site Coordinate for ETQ Deviations to ensure deviations are routed to contributors for action
- Develop the Quality Management System to support Operational Excellence, Lean, CAV and BIQ methodologies
47
Quality Systems Engineer Resume Examples & Samples
- Bachelor’s degree in a scientific or technical field
- 3+ years of experience in the medical device industry
- Working knowledge of GMP’s and other FDA regulations
- Experience validating application activities
- Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions
- Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications
- Proven analytical capabilities
- Excellent communication, organizational and project management skills
- Successful experience working with cross functional teams across multiple work locations
- Effective written and oral communications skills and computer skills required
- Network oriented and able to interact with different business functions and can work within numerous systems
- Work cooperatively in a team environment
48
Quality Systems Engineer Resume Examples & Samples
- Using “Quality” principles, implement and maintain a division wide continuous improvement quality system that ensures a high level of customer satisfaction combined with a low level of customer complaints
- Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement
- Responsible for creating audit plans and ensuring that quality systems and products are produced to Trinity Highway Products standards and specifications
- Maintain and update key supplier audit system and schedule
- Interaction with Supply Chain to monitor, communicate and improve key supply chain KPI’s, including Supplier OTD (Past due), DPPM and
- Drive “Zero Defect” mentality within the supply base
- Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
- Establish specific short / long term supplier quality goals
- Identify improvement opportunities and apply scientific methods, statistics and problem solving techniques to improve and sustain product quality and process effectiveness
- Support the development and administration of the customer corrective and preventative action (CAPA)
- Adapt six sigma methodology into process improvement, monitoring and analyzing data to identify non-value-added steps
- Assist with the development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
- Research and introduce innovative technologies to replace antiquated processes for better process repeatability and efficiencies
- Compile & write training material and conduct training sessions on improvement tools & methodologies
- Plan and execute projects and team activities to facilitate changes that have a statistical impact on business results, especially as it relates to meeting and exceeding customer expectations
- Bachelor’s Degree in Quality, Operations, Manufacturing, Supply Chain or other related field preferred or equivalent experience and certification
- Possess effective interpersonal skills in a team environment
- Must be project-oriented and be able to multi-task
- Knowledge/proficiency with Microsoft Office applications, including Microsoft PowerPoint, Microsoft Project, Excel, Visio and Word
- Certified by the Society for Quality (ASQ) as a Certified Quality Engineer (CQE). desired
- CQA (Certified Quality Auditor) status through ASQ (American Society for Quality) desired
- Knowledge of various quality system methodologies 8D, Lean, 5 Why’s, Pareto Analysis, Six Sigma, 8-D, PFEMA, PPAP, preferred
- ISO 9001:2015 knowledge preferred
49
Quality Systems Engineer Resume Examples & Samples
- Bachelor in Industrial, Mechanical, or similar
- 3 to 5 years of experience within Automotive Industry or similar
- Proven experience on QMS implementation (ISO/TS 16949, IATF 16949, VDA 6.3)
- Proven knowledge of Automotive Regulations (IATF, AIAG, etc.)
- Able to manage multidisciplinary teams
- Hands on experience with Internal, External, and Third Party audits
- Develops complex analysis of processes to identify systemic problems and solutions
- Skills to evaluate processes effectiveness, risks and opportunities
- Hands on knowledge on customer requirements and portals
- Uses stablished guidelines, procedures and policies to meet objectives
- Seeks for continuous improvement of the QMS
- Promotes company values at all times
- Develops his/her team members
50
Quality Systems Engineer Resume Examples & Samples
- Develop, author, and release corporate Quality Management System procedures for the Medical Device industry
- Support deployment of procedures in local entities' Quality Management System
- Bachelor’s degree, preferably in a scientific discipline
- Minimum of 7 years of experience working in Quality Systems supporting multiple functional disciplines within a global medical device industry
- Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
- Proven experience in creating and releasing Quality Management System procedures
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance
- Strong communication and writing skills with high detail orientation
- Mastery of the English (US) language with an "affinity" for grammar
- Strong knowledge of computers and Microsoft Office
- This position requires extensive knowledge of FDA QSRs, ISO 13485, ISO 9001, and other worldwide Quality System Regulations
51
Quality Systems Engineer Resume Examples & Samples
- 4 year degree in an Engineering field
- Ability to work effectively in cross-functional teams
- Demonstrated project management and/or organizational skills
- Working knowledge of MS Office, including Word, Excel, and Outlook
- Experience in the medical device field
- Experience in process verification and validation procedures
- Experience with development analysis, evaluation, and testing of medical systems
- Understanding of manufacturing and quality standards
52
Quality Systems Engineer Resume Examples & Samples
- Provide direction and support for multiple company locations adopting changes to the global Quality System framework
- Manage projects for QS CAPA in North America
- Ensure alignment with corporate standards and CGMP guidelines as well as assisting in increasing reported quality metrics
- Provide coaching and mentoring to global process owners through effective support of QMS
- Collaborate with management from all sites to facilitate and ensure company practices are consistent and compliant
- Facilitate meetings to engage global leadership on Quality System framework and initiatives
- Create, maintain and utilize a “Standard Work” approach to perform tasks and produce deliverables needed to support teams, develop solutions and manage projects
- Manage cross-functional teams to meet project plans including timelines and budgets
- Support quality metrics: collect, maintain, trend, and analyze data
- Collaborate across the organization at all functional levels and locations
- Implement and Utilize tools to drive compliant and effective processes
- Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, and other key performance indicators
- Provide interpretations and training as needed
- Subject matter expertise in Quality Systems for medical devices
- Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical device development and manufacturing
- Ability to organize complex information into meaningful structures appropriate for diverse audiences
- Possess a broad knowledge of functional areas impacted by Quality Systems
- Demonstrated track record of systematically improving global Quality Systems
- Experience in leading cross functional teams
- Project management skills, including: set priorities, analyze risks, and make appropriate judgments and decisions
- Ability to work individually with minimal supervision and as part of team
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Quality Systems Engineer Resume Examples & Samples
- Bachelors Degree (BSE) or related degree preferred
- A minimum 2 years of experience or related work experience is required
- Additional experience may be considered in lieu of the educational requirements
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Quality Systems Engineer Resume Examples & Samples
- Reporting Research Results
- Technical Understanding
- Promoting Process Improvement
- Developing Standards
- Managing Processes
- Manufacturing Methods and Procedures
- Supports Innovation
- Operations Research
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Quality Systems Engineer Resume Examples & Samples
- Provide QA support for pass-through product by handling customer quality concerns, issuing PPAP’s to the customer, working & communicating with the product manufacturing facilities, coordinating and managing product warranty activity & working with appropriate support departments in proper handling, disposition, and shipping of product
- Oversee the training and communication of Hitachi Global Standards to the local staff to include oversight of training schedule, tracking and communicating revisions, conducting training sessions, communicating with HQ in Japan, and assisting in standard implementation in the organization
- Provide oversight of the change management/APQP activities of product commodity teams to assure that internal and external requirements are met according to prescribed schedules. Activities to include
- Supporting and communicating with cross-functional team members
- Scheduling and leading routine meetings with cross-functional program team members
- Maintaining records and minutes of team review meetings
- Updating and managing any related APQP tracking spreadsheets and/or software for team communication and change implementation monitoring
- Interfacing with customers and suppliers as needed
- Assuring that the implementation of all product/process changes meet completion timing, product quality, documentation completion, and all related standards
- Responsible for escalating to management any potential risks that would prevent meeting the above requirements
- Participate on the Quality Systems Internal Audit Team
- 5-10 years experience in an automotive environment, familiarity with ISO/TS standards. Previous quality experience preferred
- Must have experience in an MS Office environment. (Word, Excel, PowerPoint and Access). Moderate keyboarding skills needed
- Familiarity and/or experience with Advanced Product Quality Planning and leading a project team
- Requires good presentation and meeting management skills
- Good organization, communication, and attention to detail is a must
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Quality Systems Engineer Resume Examples & Samples
- Provide quality systems support to Silgan's manufacturing facilities in order to enable process improvement and reduce variability
- Lead our customer and vendor certification process
- Establish and validate our process and product monitoring methodologies as well as review and evaluate our quality processes in our manufacturing facilities
- Develop sampling plans, inspection procedures and SOP's for assigned customer groups
- Bachelor's Degree; a degree in a technical discipline is preferred
- At least 3 years prior experience in a manufacturing or quality role
- ASQC - Certified Quality Engineer is preferred
- Experience in Food Safety (GFSI) is highly recommended
- This role requires the ability to travel at least 50% of the time, sometimes on short or little notice
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Quality Systems Engineer Resume Examples & Samples
- Provides Quality System Body of Knowledge support to organization
- Investigates, and resolves system nonconformance’s (defined during internal and/or external audits
- Develops QS related reports (i.e. Quality plans, reports, process documentation) to support business activities
- Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and leads activities to implement improvements
- As appropriate, utilizes quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in quality system compliance, device, and process
- Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements
- As appropriate, support teams in quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
- As appropriate, support completion and maintenance of risk analysis, as related to quality systems
- Support of core Quality System activities (e.g. Management Review preparation, External Standards, Org Responsibility, Quality Manual) to meet process requirements
- BS degree in Engineering or Technical Field or equivalent experience
- 0-2 years’ experience
- Engineering experience preferred
- Knowledge of Quality tools/methodologies
- Solid communication and interpersonal skills
- Advanced computer skills, including statistical/data analysis and report writing skills
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
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Quality Systems Engineer Resume Examples & Samples
- Support the Global Internal Audit function through participation in Internal Audit community meetings and projects
- Identify and lead continuous improvement opportunities in the Internal Audit function
- Work with Internal Audit team, Global Internal Audit function, and other BSC sites to continuously improve approach to product and process focused audits
- Participate within the Quality Systems team as a team member supporting various compliance initiatives, including one-off internal audit requests, mock audits, back-up external audit Subject Matter Expert, etc
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Bachelor Degree in the Engineering or Science field, plus 2-4 years of related experience or an equivalent combination of education and work experience
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Proficient and comfortable leading audits within a medical device regulated environment to criteria including external regulations 21 CFR Part 820 and ISO 13485
- Easily and clearly communicates status updates and results of auditing activities to auditees throughout the internal audit process
- Knowledge of additional external regulations, including 21 CFR Part 4, 21 CFR Part 11, ISO 14971, Medical Device Directive 93/42/EEC , Therapeutic Goods (Medical Devices) Regulations, MHLW Ministerial Ordinance No. 169, SOR/98-282, and RESOLUTION RDC Nº 16
- Experience with CAPA, Management Review / Controls, and External Audits
- Flexible and positive attitude
- Computer literate, network knowledge required
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Iatf Quality Systems Engineer Resume Examples & Samples
- 5 years minimum of Quality experience in a Manufacturing environment
- Knowledge of automotive quality standards and tools including APQP, PPAP, FMEA, MSA, 8Ds, SPC
- Experience in Automotive Industry requirements
- ISO/TS 16949 experience and certification required. Lead Auditor preferred
- Extensive experience leading Internal Audit activities
- IATF Expert Certification a plus
- CQE Certification desired
- Bilingual (English-Spanish) 80%
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Quality Systems Engineer Resume Examples & Samples
- Responsible for coordinating and managing all external audits
- Responsible for managing the site internal audit process
- Responsible for managing the site internal CAPA process
- Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis)
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Quality & Systems Engineer Resume Examples & Samples
- Assist the Quality Assurance Manager in coordinating the development and implementation of activities related to Unimotion-Gear’s Quality Management System. Stay current on new quality initiatives and promote best in class benchmarking
- In conjunction with the Quality Assurance team, Engineering and Production, participate in the development and improvement of process FMEA’s and Control Plans
- Lead the team in 5 WHY analysis for any quality issues, and complete all sections of the 8D process
- Work to continuously improve the quality of the product, and reduce scrap using A3 methodology
- Support Quality Management System by ensuring standards related to IATF 16949, GQS, MAFACT and Customer Specific Requirement are current and appropriately distributed
- Develop the internal audit schedule and update as required
- Ensure all internal audits are conducted in a timely manner, and that corrective actions are being implemented according to internal procedure
- Ensure the active duties of maintaining ISO/IATF 16949 certification are achieved
- Assist the management team in coordinating the development and implementation of activities related to the Division’s IATF 16949 quality system standards
- Assist in the development of Quality Engineers in the proper use of Core Tools (FMEA, SPC, Control Plans, APQP, PPAP, MSA) etc
- Lead Role in maintaining Customer Specific Requirements to maintain Q1, JLRQ, and BIQ rating
- Perform lead auditor duties for QMS internal auditing including providing audit schedules, providing management with audit results, and leading in closing out corrective action issues
- Ensure QMS customer requirements are made available to appropriate departments within Unimotion-Gear
- Lead auditor duties for QMS internal auditing, including providing audit schedules, providing management with audit results and leading in closing out corrective actions issues
- Data and document control for IATF 16949
- Lead role in surveillance and registration audits for QMS including scheduling third party audits
- Make all documentation available on the network and maintain one master hard copy as a contingency
- Provide meaningful statistics to the Quality Manager in a timely manner to assist in continued improvement of workplace
- Work with all other departments within UMG to carry out any engineering changes or quality procedure changes to ensure all instructions are continuously improved and current
- Assist in responding to internally or externally generated non-conformances
- Work as a team member and pass on skills, knowledge and/or understanding of Unimotion-Gear to new employees
- Supports all plant IATF 16949 & ISO initiatives & requirements
- Comply with the applicable responsibilities related to effective quality management in accordance with Unimotion-Gear’s Quality Management System (QMS) IATF 16949
- Perform other duties as assigned by the Quality Assurance Manager
- College Diploma in a quality related field
- Certified Quality Engineer/Technician certification or equivalent required
- Three (3) to four (4) years’ experience with quality systems and system auditing in an automotive manufacturing environment
- Able to travel outside of Canada to customer and supplier sites when required
- Demonstrated knowledge and understanding of automotive blueprint reading, dimensional measurement, advanced SPC, design of gauging, DOE, PPAP, APQP, PFMEA, IATF 16949
- Lead auditor certified to ISO/ TS / IATF16949 requirements
- Able to work overtime as required
- Excellent ability to communicate and interact with people at all levels, both inside and outside the organization
- Proficient in Windows, Word, Excel and Microsoft Outlook
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Quality Systems Engineer Resume Examples & Samples
- Working with existing users with use of the application
- Creating and maintaining Work Instructions & Training Material for end-users and administrators alike
- Development of robust promotion and product testing processes to ensure application reliability
- Working with business users to assess and understand business needs
- Developing functionality to support these business needs
- Resolving issues within the application through use of problem-solving techniques, interaction with internal IT organization and vendor’s support system
- Understand our customer requirements through use of Customer supplier portals
- Maintain and develop SharePoint sites to support business needs, through
- Interaction with stakeholders, assessment of needs determination and implementation of appropriate solutions
- 50%: Leading sites (manufacturing and distribution) through the implementation of Reliance for document control
- 30%: Providing support to existing sites with use of Reliance with user provisioning and training
- 20%: Participating in requirements gathering, design, configuration, testing and documentation of new modules within the application
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Quality Systems Engineer Resume Examples & Samples
- Internal IATF 16949 Audits – including audits conducted by Bosch Automotive Steering Germany
- Customer Audits
- Fulfill required responsibilities as the assigned Management Representative for the Bosch Automotive Steering Florence / Plymouth IATF 16949 QMS
- Responsible for being the Primary Contact and Coordinator for the Audits and Audit Responses
- Schedule the applicable Departments to be available for the Audits
- Schedule and conduct meetings with Departments to review Audit Findings, Corrective Action Development, and Corrective Action Implementation
- Verify effectiveness of the Corrective Actions by re-auditing the Corrective Actions several months after initial implementation of the Corrective Actions
- Initiate changes / improvements to the Bosch Automotive Steering Florence / Plymouth QMS to ensure compliance to the IATF 16949 Standard
- Review Bosch Automotive Steering Corporate Guidelines and Directives to determine applicability to ZFLS Florence / Plymouth
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Quality Systems Engineer Resume Examples & Samples
- Fully supports the AS9100 Project Manager in the
- Analysis of in place quality management system
- Authorship of necessary manual(s)
- Revision of affected supporting documents
- Implementation of the above and training of the workforce
- Scheduling and hosting required audits related to the project
- Driving corrective actions in response to those audits
- Ongoing direction and maintenance of the quality system following implementation
- Actively participates in and promotes continuous improvement initiatives as required to meet company targets in Safety, Quality, Productivity, and Cost
- Other tasks as appropriate and as assigned by management
- 4 year degree in Engineering or science discipline
- Two years of experience in the administration of AS9100 quality management systems or five years directly related experience
- Ability to follow SOPs and maintain quality standards
- Ability to adjust and prioritize work to meet deadlines
- Strong communication, organizational and teamwork skills
- Strong computer skills (Microsoft Office required)
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Quality Systems Engineer Resume Examples & Samples
- Analyses data outputs from processes to identify improvement opportunities (COS audits, systems audits, process audits, LPA’s, CAR / PAR)
- Pro-actively identifies process and system improvements, develops improvement plans and leads implementation
- Lead Continuous Improvement projects across the sites
- Manages and develops systems and process audit functions within the plant. Constantly review the process to ensure continued effectiveness and identification of improvement opportunities
- Lead the Integration of the transition to the new IATF standard from TS 16949
- Maintain IATF Standards across the site to ensure re-certification status year on year
- Experience working with TS16949, ensuring the whole site is adhering to the standard
- Fully qualified (Degree/ HNC/HND)
- Six Sigma qualified would be advantageous
