Staff Supplier Quality Engineer Resume Samples

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LF
L Feeney
Lavern
Feeney
310 Susanna Avenue
Los Angeles
CA
+1 (555) 557 0339
310 Susanna Avenue
Los Angeles
CA
Phone
p +1 (555) 557 0339
Experience Experience
11/2015 present
Boston, MA
Senior Staff Supplier Quality Engineer
Boston, MA
Senior Staff Supplier Quality Engineer
11/2015 present
Boston, MA
Senior Staff Supplier Quality Engineer
11/2015 present
  • Work with purchasing representatives to ensure Applied Technology supplier management processes comply with ISO 9001
  • Monitor supplier performance and report supplier quality trend data to management
  • Function as liaison between purchasing, engineering, manufacturing and suppliers to resolve supplier issues and to provide technical support
  • Request, develop and monitor supplier corrective and preventative action plans and activities as necessary
  • Determine cause of supplier problems and coordinate/implement effective and timely resolutions
  • Participate in the timely disposition of nonconforming material as it relates to supplier responsibility
  • Travel to supplier sites to resolve nonconforming material concerns
05/2009 06/2015
New York, NY
WW Staff Supplier Quality Engineer
New York, NY
WW Staff Supplier Quality Engineer
05/2009 06/2015
New York, NY
WW Staff Supplier Quality Engineer
05/2009 06/2015
  • Support development and automation of supplier quality metrics which drive supplier improvement through targeted KPI performance
  • Continually assess the Supplier Management and QA Management system and SOPs for continual improvement
  • Develop and execute comprehensive quality strategies for design development, verification and validation
  • Performs other duties as assigned by management
  • Visit suppliers to resolve product performance & development timing concerns
  • Initiate and manage projects to improve quality, yields and value received from the supply base
  • Support various quality management system improvement projects
04/2005 04/2009
San Francisco, CA
Staff Supplier Quality Engineer
San Francisco, CA
Staff Supplier Quality Engineer
04/2005 04/2009
San Francisco, CA
Staff Supplier Quality Engineer
04/2005 04/2009
  • Method Validation, Sampling Plans Development and Review, and Supplier Management and Certification
  • Continue to develop and improve the technical assessment process, including incorporating best practices and lessons learned
  • Disposition nonconforming material and develop tactics to eliminate it
  • Serve as a leader within the Supplier Quality Engineering Organization, providing guidance to other team members as necessary
  • Perform supplier audits on potential and current suppliers
  • Develop systems to ensure quality of purchased raw materials and finished foods
  • Maintain global processes that govern Counterfeit Risk Management
Education Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Florida International University
Bachelor’s Degree in Engineering
Skills Skills
  • Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills)
  • Ability to work effectively in a team environment and build strong working relationships
  • Strong background and experience in NPI Quality for instrumentation hardware and qualification
  • Supports the development of quality engineering and quality compliance with the right skill sets for product life cycle management
  • Strong team player with ability to work effectively on cross-functional teams
  • Demonstrated ability and skills to support supplier development activities, continuous improvement initiatives and quality management tools
  • Develop systems to ensure quality of purchased raw materials and finished foods
  • Ensure effective risk management to prevent unanticipated failure modes and ensure capability
  • Strong analytical and problem-solving skills
  • Excellent communication skills; both verbal and written
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1

Staff Supplier Quality Engineer Resume Examples & Samples

  • A minimum of a Bachelor's Degree is required; a degree in Engineering, Life Science, or related discipline is preferred
  • A minimum of 6 years experience in a GMP and/or ISO regulated industry is required, experience in the medical device and/or pharmaceutical industry is preferred
  • FDA and ISO regulations knowledge is required; FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
  • Auditing background is highly desirable
  • Experience and/or knowledge with machining manufacturing processes and injection molding are preferred
  • Six Sigma, Lean, or ASQ Certification and training are preferred
  • Experience with CNC Milling and Turning; Press Breaking and Punching, Assembly; Metal Laser Etch; Silk-Screen, and Metal Processing such as passivating, anodizing and heat treating are an asset
  • This position will be based in West Chester, PA, and will require up to 25% travel.Quality (Eng)
2

WW Staff Supplier Quality Engineer Resume Examples & Samples

  • A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical field is required
  • A minimum of 6 years of experience in data analysis, risk assessment and risk mitigation is required
  • Medical Device or Pharmaceutical industry experience is preferred
  • Quality Assurance experience is preferred
  • Quality Engineering experience is preferred
  • Knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) required
  • Knowledge of Non-Conformance Reports (NCRs) is preferred
  • Knowledge of Corrective and Preventative Actions (CAPAs) preferred
  • Process Validation experience in new product introduction is preferred
  • Project management experience is preferred
  • Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
  • Experience with Microsoft Visio is preferred
  • Experience with Microsoft Project is preferred
  • Experience with Minitab is preferred
  • Knowledge of Process Excellence tools (Lean, Six Sigma) preferred
  • Lean or Six Sigma Green Belt or Black Belt preferred
  • ASQ certification (CQE, CQA) is preferred
  • Must have strong business acumen
  • Must have the ability to collaborate will all levels of management in cross-functional team environment
  • This position will require up to 15% domestic and international travel
3

Staff Supplier Quality Engineer Resume Examples & Samples

  • Coordinate cross functional teams to assess supplier capabilities and opportunities for improvements by performing Technical Assessments of our suppliers (direct material and external manufacturers). Track findings (including appropriate effectiveness checks), ensure corrective actions are adequate and addressed in a timely manner and maintain quantitative and qualitative data that tracks the ongoing performance of the Enterprise supply base
  • Create executive summary and proactively communicate any risk identified during assessment, ensuring proper escalation to the business
  • Interacts and collaborate with the following teams on a regular basis: External Operations, Sourcing, Partner Development and Engineering, Compliance, Category Teams, and others as required
  • Ensure supplier performance is monitored, addressed and escalated as needed related to Technical Assessments
  • Ensure effective and efficient use of PE tools and Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control while performing assessments at our suppliers
  • Utilize technical expertise specific to applicable categories (ex. Plastics, API/Bio, Packaging, Chemicals, and Metals) to ensure robust assessments of suppliers and corrective action closure
  • Continue to develop and improve the technical assessment process, including incorporating best practices and lessons learned
  • Identify improvements to the technical assessment program based on the technical expertise of the processes and technologies being assessed
  • Train and mentor Senior Supplier Quality Engineers – Technical Assessments
  • At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science. Minimum of 4 years of experience in technical areas
  • Certified Quality Engineer and Certified Quality Auditor (ASQ or equivalent) preferred
  • Experience in the following categories are preferred: Plastics, API/Bio, Packaging, Chemicals, and Metal
  • Experience in performing audits and/or technical assessments is required
  • Experience in mentoring/coaching is required
  • Green Belt or Black Belt certification is preferred. Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence preferred
  • Strong understanding of Medical Device and/or Pharmaceutical Regulations is required (i.e. 21 CFR Parts 820, 210, 211, 600, 601, 610, 1270, 1271, ISO 13485, ICH Quality (Q1-Q12) )
  • Must have excellent communication skills. Ability to communicate clearly and concisely across all levels of the organization and across Global Supply Chain is required
  • Ability to foster an effective multi-functional, cross region, cross company team environment is required
  • Ability to forge strong collaboration and teaming with suppliers and internal stakeholders
  • 50-70 % domestic and international travelQuality (Eng)
4

Staff Supplier Quality Engineer Resume Examples & Samples

  • Maintains, enforces, and measures supplier quality processes, including Aggregate Failure/Quality Tracking by commodity
  • Maintains the Quality System and its subparts as related to Supplier Quality
  • Provides topical knowledge in applicable domestic and international regulations and standards e.g., QSR, MDD, 13485 and CMDCAS
  • Minimum of 10%-15% travel
  • Commodity Specific Technical Expertise (PCBA, Wire Harnesses, Machining, Sheet Metal, Molded Plastics, and OEM)
  • Supplier / Project Management Experience
  • Demonstrated Collaboration, Negotiation & Conflict Resolution Skills
  • Supplier Audit and or Lead Assessor Experience
  • Knowledge of Quality System Standards QSR, ISO3485 and ISO9001
5

Staff Supplier Quality Engineer Resume Examples & Samples

  • Drive supplier quality and productivity improvement
  • Conduct onsite supplier quality assessments and drive closure of findings
  • Implement TE supplier quality strategies, procedures and initiatives
  • Monitor and track supplier APQP activity through PPAP
  • Lead manufacturability reviews with the suppliers and present VOS to TE project teams
  • Facilitate rapid resolution of critical supplier quality issues
  • Organize containment activities and/or production monitoring on a need-to-support basis
  • Ensure timely implementation of permanent corrective actions and resolution
  • Enforce supplier compliance to TE supplier quality manual
  • Audit skills with TS and/or ISO system background
  • Ability to train and lead: APQP, FMEA’s, Control Plan, Run at Rate, PPAP
  • Strong team player with ability to work effectively on cross-functional teams
  • Ability to travel as required. Estimated 30% - 60%
  • Certified problem solver: 8-D, Red-X, Six Sigma Green Belt a plus
  • Excellent communication skills; both verbal and written
  • Bachelor’s Degree in Business or Technical discipline; or equivalent experience
  • Minimum 3 years SQE experience in manufacturing quality (automotive a plus)
  • Demonstrated self-starter and able to work independently to execute strategies and meet goals
  • Experience with the following materials and processes is preferred
6

Senior Staff Supplier Quality Engineer Resume Examples & Samples

  • Degree Holder from a recognized university with 4 years experience preferred
  • Working experience as Process/ Supplier/ Customer Quality will be an added advantage
  • Knowledge on ISO 9001/ CCC/ ROSH/ UL
  • Able to communicate and write in English and Mandarin
  • Knowledge of 8D methodology and other QC tools e.g. SPC, 5S , Kaizen etc
7

Staff Supplier Quality Engineer Resume Examples & Samples

  • Supervision of Technicians
  • Changing the way we do business – continuously improving our policies and procedures
  • Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities
  • A minimum of a Bachelor's degree is required. A degree in Engineering, Life Science, Physical Science or a related field is preferred. An advanced degree is also preferred
  • A minimum of 6 years Quality experience or related experience is required
  • Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
  • Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is preferred
  • An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset. Prior project management experience is preferred
  • Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred
  • It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc
  • This position is located in Cincinnati, OH and may require up to 25% of both international and domestic travel
8

Staff Supplier Quality Engineer Resume Examples & Samples

  • Component development as part of New Product or Process Introduction
  • Selection of suppliers for highly engineered components
  • Implementation of Critical to Quality requirements for externally manufactured components ensuring robust processes at suppliers that meet CTQ’s
  • Qualification of highly engineered components including validation, requirements review, risk management such as FMEA’s and Control plans, Test Method validation and measurement system analysis, Development of inspection strategies
  • Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements
  • Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis)
  • Leading or contributing to the reliability assessments of product design
  • Leading and/or contributing to root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions
  • Conducting and supporting the development of, test methods in equipment, process, and product qualifications/validations
  • Developing, implementing, and/or maintaining process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed
  • Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics). Perform or guide Measurement Systems Analysis (MSA)
  • Mentoring others in various technical capabilities
  • Interpreting standard and non-standard sampling plans
  • Participating in technical reviews as appropriate
  • Supporting execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies
  • Design control
  • Good documentation practices
  • Good manufacturing practices
  • Organizational requirements
  • Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations -
9

Staff Supplier Quality Engineer Resume Examples & Samples

  • Self-manage required supplier audits from scheduling through to closure of the audit
  • Core team member of new product development focused on required activities for set up of new suppliers / oversight of supplier validations / transfer of processes to suppliers
  • Identify and manage supplier corrective actions and follow-up to assure completion and effectiveness
  • Support various quality management system improvement projects
  • Proactively develop and maintain broad knowledge and current technologies in the applicable functional quality system discipline(s)
  • Participate as a team member with other Edwards’ associates and facilities to assure a consistent application of the assigned Quality System element(s)
  • Bachelor Degree in engineering required
  • Candidates with at least 5 years’ experience in medical devices are highly preferred
  • Knowledge and understanding of FDA and international regulatory standards for medical devices is highly preferred
  • This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills are required
  • Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required
  • Certified Lead Auditor / ASQ Certified Biomedical Auditor preferred
  • Domestic and international travel is required. Expected 25% travel
10

Staff Supplier Quality Engineer Resume Examples & Samples

  • Lead the planning and execution of new supplier material qualification
  • Represent Supplier Quality Engineering on New Product Development teams & provide guidance on the appropriate selection of suppliers
  • Perform supplier audits on potential and current suppliers
  • Visit suppliers to resolve product performance & development timing concerns
  • Develop supplier material control plans and incoming material inspection plans
  • Serve as a leader within the Supplier Quality Engineering Organization, providing guidance to other team members as necessary
  • Bachelor's degree in an engineering field with 9+ years experience
  • OR Master's degree in field with 7+ years experience
  • OR Doctoral degree in field with 4+ years experience
  • Expertise in ISO 9001 based quality systems
  • Experience working with ERP systems such as Oracle
  • Strong leadership abilities. Experience with direct supervision is a plus
  • Proficient in the use of Minitab
  • Understanding and experience with performance and evaluation of process capability studies
  • Project management capabilities
11

Staff Supplier Quality Engineer Resume Examples & Samples

  • Utilize Quality Engineering tools for the effective and efficient development and maintenance of raw material suppliers
  • Utilize quality engineering principles and problem solving skills to develop and optimize supplier performance that are aligned with the overall Quality and Business vision
  • Ensure effective risk management to prevent unanticipated failure modes and ensure capability
  • Partner with Engineering, Procurement and Suppliers to ensure the application of process validation, process control, and process risk management
  • Partner with Engineering, Procurement and Suppliers in the investigation/correction of process failures
  • Implement and monitor process capability for continuous improvement at supplier end
  • Ensure effective supplier initiated base business change control
  • Proactively communicate with DQE any base business changes in design or changes in process that could affect product design
  • Develop systems to ensure quality of purchased raw materials and finished foods
  • Ensure supplier performance is monitored, reviewed and addressed as needed. Provide leading metrics to site as per applicable forums
  • Utilize technical skills specific to assigned commodities (Packaging & Chemicals Categories to ensure adequate quality and control plans based on critical to quality requirements
  • Partners in new supplier selection with Procurement & In-Direct Source partners
  • Participate with the Procurement in the supplier business review meetings held with the supplier
  • Analyzes quality data and identifies trends impacting risk benefits requirements of product and quality systems for external suppliers. Leads discussions to drive resolution
  • Provides recommendations or proposed changes to components based on data analysis using Process Excellence tools
  • Ability to effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management lifecycle
  • Serves as an auditee for supplier audits based on yearly audit schedule. May serve as lead auditor for supplier audit and technical assessment. Effectively evaluates suppliers against applicable regulations
  • Prepares Quality Agreements and drives discussion with supplier while consulting SQ Management
  • Assist in the maintenance of the supplier quality relationship(follow-up of corrective actions, coding for metrics, etc.)
  • Leads component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
  • Ensures compliance with company policies and procedures such as Design Control, Process Validation, Test
  • Method Validation, Sampling Plans Development and Review, and Supplier Management and Certification
  • Update site on supplier quality metrics and performance at the Local Management Review of the Quality System and the Management Review Board. Compiles and recommends data driven conclusions for Management Revie
  • Update site on Supplier Quality Metrics on Monthly basis during monthly QDAR , Customer Service , PSLT meetings
  • Develop, write and approve as required policies, procedures, test methods, specifications
  • Serves as SME for Purchasing Controls procedures and champions the management of changes to MD Standards within Ethicon. Supports and lead activities in support of the MDD Supplier Quality Program to achieve established goals and objectives
  • Proactively communicate with Procurement Management, and local engineering relative to any changes in design, material, or process by assigned suppliers that could affect product design
  • Responds proactively to changing regulatory and business needs
  • To handle/lead product recall initiated because of supplier issues
  • Experience working in an FDA regulatory environment is preferred
  • This position will require relevant experience working in a manufacturing/operations environment
  • Knowledge of product/process Risk Management (FDA and ISO standards) is required
  • Experience with implementation of risk mitigation is preferred
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc
  • Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
  • The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired
  • Good technical understanding of manufacturing equipment and processes is required
  • Process Validation expertise is preferred
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Demonstrated knowledge and application of QSR, MDD 93/42/EEC, ISO9001, ISO13485,14971 and other international standards
  • Demonstrated project management and project leadership abilities are preferred
  • Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project)
  • Effective written and oral skills
  • This position may require travel and will be based in a supplier location and/or Ethicon Facility.Quality (Eng)
12

Staff Supplier Quality Engineer Resume Examples & Samples

  • Provide strategic direction and systems of execution for Quality-related elements of supplier management activities, inclusive of; incoming inspection processes, supplier qualification, supplier monitoring, etc
  • Planning, co-ordination and execution of supplier audit program based on appropriate risk analysis, managing corrective action activities related to both initial qualification and on-going improvement of suppliers' quality execution capabilities
  • Support development and automation of supplier quality metrics which drive supplier improvement through targeted KPI performance
  • Support product introduction and transfer activities, including part-qualification with suppliers
  • Support sites on part problem resolution through all phases of product realization
  • Participates in customer-facing supplier quality activities
  • Support and develop site, regional & global Quality Management System elements related to supplier management to meet requirements across all key business sectors, Defense/Security/Aerospace, Healthcare/Life Sciences, etc
  • Support Sourcing/Materials on alternative supplier selection
  • Mentor and support site personnel on supplier quality activities and process effectiveness
  • Minimal travel may be required to meet the needs of the business (estimated 20-30%)
  • A minimum of a Bachelor’s degree or equivalent experience is required for this position; a Bachelor’s degree in Engineering or a similar field is highly preferred
  • Experience of 5 years is required for this position, assuming education requirements are met
  • ASQ Certification preferred (CQE, CQA, CMQOE)
  • Broad understanding of materials, manufacturing technologies and processes    
  • Advanced decision making and problem solving skills required
  • Advanced industry/manufacturing knowledge is preferred
  • Advanced statistical analysis knowledge is preferred
13

Staff Supplier Quality Engineer Resume Examples & Samples

  • Support external suppliers through managing the qualification of supplier products and processes, analyzing and resolving supplier quality issues
  • Initiate and manage projects to improve quality, yields and value received from the supply base
  • Develop and execute comprehensive quality strategies for design development, verification and validation
  • Partner with Procurement, GTO, R&D, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady state manufacturing
  • Participate in evaluation and selection of potential suppliers and external manufacturers
  • Support/manage base-business activities
  • Bachelor’s degree in Engineering/Science field is required, Master’s degree is preferred
  • A minimum number of 6 years of equivalent experience is required
  • Must possess knowledge of working in Medical Device industry
  • Familiarity with FDA regulated environment
  • Knowledge of manufacturing methods (SMT, injection molding, mechanical assembly and test)
  • Knowledge of supplier and external Manufacturing Quality Management experience desired
  • Serve as the technical expert for supplier quality and assigned area of expertise, with conceptual knowledge of all functions and business areas
  • Drive innovation within functional area
  • Builds cross-functional and cross-departmental support, fostering overall group effectiveness
  • Ability to influence others to achieve business objectives
  • Ability to support/manage multiple projects simultaneously, ability to fluently change priorities based upon business needQuality (Eng)
14

Staff Supplier Quality Engineer Resume Examples & Samples

  • Implement and monitor process capability for continuous improvement
  • Proactively communicate any base business changes in design or changes in process that could affect product design
  • Ensure supplier performance is monitored, reviewed and addressed as needed
  • Minimum degree in Engineering or equivalent in a Life Science or Physical Science
  • 3-5 years’ relevant work experience, preferred in Medical Device industry
  • Knowledge in Medical Device Packaging and Medical Device Validation is of advantage
  • Demonstrated knowledge in and application of QSR, ISO9001 and ISO13485
  • Strong influencing skills
  • Sense of urgency, intellectual curiosity, prudent risk-taking
  • Willingness to travel 30% International & Domestic is required
15

Senior Staff Supplier Quality Engineer Resume Examples & Samples

  • Function as liaison between purchasing, engineering, manufacturing and suppliers to resolve supplier issues and to provide technical support
  • Work with purchasing representatives to ensure Applied Technology supplier management processes comply with ISO 9001
  • Ensure the Applied Technology Approved Supplier List is maintained and is accurate
  • Monitor supplier performance and report supplier quality trend data to management
  • Review/audit new and existing suppliers to assess manufacturing capability and adherence to accepted quality system practices
  • Lead efforts in identifying, communicating, and resolving supplier problems
  • Request, develop and monitor supplier corrective and preventative action plans and activities as necessary
  • Determine cause of supplier problems and coordinate/implement effective and timely resolutions
  • Participate in the timely disposition of nonconforming material as it relates to supplier responsibility
  • Travel to supplier sites to resolve nonconforming material concerns
  • Perform other responsibilities within the quality function commensurate with individual skill set
  • Bachelors Degree in Mechanical Engineering, Electrical Engineering, or equivalent discipline
  • 5-10 years experience in supplier quality or quality engineering
  • Skilled in the application of statistical methods (e.g. ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments)
  • Working knowledge of CAPA and associated problem solving disciplines (e.g. 8D, 5 Whys)
  • Quality engineering experience in automotive or military/aerospace industries is a plus
  • Certified Green Belt or Black Belt is a plus
  • Excellent interpersonal and communications skills are vital in this role
  • Must be a U.S. citizen with ability to obtain necessary security clearance as required by government contract
16

Staff Supplier Quality Engineer Resume Examples & Samples

  • Manage non-conformances related to supplier non-conformances
  • Manage Supplier Corrective Action Requests (SCARs) from initiation to closure
  • Oversee supplier metrics
  • Continually assess the Supplier Management and QA Management system and SOPs for continual improvement
  • Will be responsible for maintain strong relationships and managing external suppliers
  • Will require up to 50% domestic and international travel
17

Staff Supplier Quality Engineer Resume Examples & Samples

  • A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset. An advanced degree is preferred
  • A minimum of 6 years Quality/Manufacturing experience or related experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
  • Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc
18

Staff Supplier Quality Engineer Resume Examples & Samples

  • Bachelor Degree with focus in Electrical/Electronic Engineering or Materials Science
  • 8+ years of experience in a quality role or Manufacturing Engineering supporting high volume manufacturing
  • Familiar with industry quality standards and reliability requirements
  • Deep knowledge of Quality Management Systems, Quality procedures, and application of Quality Tools (e.g. 8D, MSA, SPC, Yield Analysis, etc.)
  • Experience with Semiconductor manufacturing process and IC fabrication. Knowledge of device level reliability test methods and failure analysis
  • Demonstrate excellent communication skills (verbal, written, presentation, and negotiation) both in English and Mandarin
  • Excellent interpersonal skills with ability to work in highly cross-functional and geographically dispersed organizations. Must be a strong team player and very self-motivated individual
  • Domestic and International travel required (15%)
19

Staff Supplier Quality Engineer Resume Examples & Samples

  • Provide leadership in design in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products
  • Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction
  • Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems
  • Provide review and approvals for the release of new products ensuring quality requirements are met
  • Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking
  • Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers
  • Responsible for following and administering safety
  • Compliance with safety policies and procedures
  • Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable
  • Other responsibilities may be assigned and not all responsibilities listed may be assigned
  • Bachelor degree in engineering- mechanical, electrical, industrial, preferred or Applicable science
  • CQE, CRE, CQA 2– Ratings, **CBA, BB preferred
  • Generally requires (6-8) years related experience
  • Bilingual: English/ Spanish
  • Negotiation / influencing
  • Quality Assertiveness
  • Analytical & Creative thinking
  • Project Management skills in order to support multiple projects simultaneously
  • Problem-solving & priority setting
  • Organizational & integral-synthesize information from a variety of sources
  • Understand concepts quickly
  • Research and maintain ongoing learning of industry and regulations
  • Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
20

Staff Supplier Quality Engineer Resume Examples & Samples

  • Strong background and experience in NPI Quality for instrumentation hardware and qualification
  • Experience in the application of production and process controls including process validation, process control plans and statistical process control
  • Superior communication skills, both oral and written
  • Ability to constructively challenge concerns and engage in transparent conversations
  • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
  • Foster an environment that values diversity and inclusion
  • Proficient with Microsoft Office (Word, Excel, PowerPoint)
21

Staff Supplier Quality Engineer Resume Examples & Samples

  • A minimum of a Bachelor's degree is required. A technical/scientific discipline is required; a degree in Engineering preferred
  • A minimum of 6-8 years of Quality/ Engineering work experience is required
  • Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
  • Practical experience with GMP documentation and writing skills in the FDA regulated environment is required
  • Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, Supplier/Purchasing Controls, SQA, material/production/process controls, and supplier certification is strongly preferred
  • Working experience of Medical Device-associated Chemicals & Textiles and Qualifications is strongly preferred
  • Demonstrated practical knowledge and skills in and application of SQM, QSRs, and ISO13485 are highly desirable
  • Professional Certification, training, or working knowledge/skills in Project Management/FPX is strongly preferred
  • Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, and/or CQA strongly preferred
  • Process Excellence Certification (J&J Six-Sigma/Lean Green Belt/Black Belt) is preferred
  • Working knowledge of Quality Risk Management tools (e.g. ISO 14971, FMEA/FMECA/FTA/HACCP, etc.) preferred
  • Familiarity with material/component/process/equipment qualifications and validations is desirable
  • The position will be based in Cornelia, GA or Athens, GA. It will require frequent visits to the Athens, GA or Cornelia, GA facility and up to travel up to 35% internationally & domestically is required
22

Staff Supplier Quality Engineer Resume Examples & Samples

  • Act as liaison for customer groups on key compliance issues
  • Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes
  • Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review
  • Drive continuous improvement activities focusing on supplier quality
  • Bachelor’s Degree in Engineering or Science fields
  • Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
  • Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
  • Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics
  • Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
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Staff Supplier Quality Engineer Resume Examples & Samples

  • Collaborates with Procurement, R&D and Operations to effectively define roles and responsibilities and supply priorities and actions
  • Ensures the Supplier Quality function operates according to procedures and provides direction to other departments. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
  • Manages the Material Review Board meetings, Supplier Review Board meetings and other critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness