Supplier Quality Engineering Resume Samples

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KU
K Upton
Korbin
Upton
5631 Johnston Land
Chicago
IL
+1 (555) 698 1068
5631 Johnston Land
Chicago
IL
Phone
p +1 (555) 698 1068
Experience Experience
09/2016 present
Phoenix, AZ
Senior Manager, Supplier Quality Engineering
Phoenix, AZ
Senior Manager, Supplier Quality Engineering
09/2016 present
Phoenix, AZ
Senior Manager, Supplier Quality Engineering
09/2016 present
  • Using the Audit results work closely with the EMS suppliers ensure the continuous improvement and closing of the open issues
  • Monitor all relevant KPIs and work towards improvements on the targets and actuals
  • Support supplier development working with Harman Procurement and Product Sourcing
  • Manage a team of global SQE EMS Engineers to perform site assessment and other activities in connection with launching new programs at EMS suppliers
  • Lead, contribute and track supplier development according to process improvement roadmap
  • Overall responsibility for global supplier development at EMS (Electronics Manufacturing Service / Outsourcing) partners
  • Define, review and rate suppliers’ artifacts to ensure effective supplier monitoring
04/2011 07/2016
Houston, TX
Supplier Quality Engineering Specialist
Houston, TX
Supplier Quality Engineering Specialist
04/2011 07/2016
Houston, TX
Supplier Quality Engineering Specialist
04/2011 07/2016
  • Evaluate the initial samples and/or engineering change requests looking for product specification compliance, assuring the planning timelines correspond to the pre-series production vehicles, start of production and serial projects of new products
  • Audit the product at the supplier and at the VW manufacturing line, making sure that it is specification compliant and the manufacturing process and quality can be granted
  • Evaluate and authorize manufacturing processes and packaging related to the CKD (Complete Knock-Down kit) logistic process, according to the corporate guidelines
  • Apply methods like DOE (Design of Experiment), 6 Sigma, CEP (Complex Event Processing), etc. to analyze the root causes of complaints. Define technical factors to be used in the Warranty Chargeback initiatives
  • Influence the development of new projects and technical concepts to achieve the continuous improvement of our product in the market
  • Recommend technical product improvements evaluating risks and potential chances to avoid quality manufacturing issues, by comparing similar parts assembly line and field development
  • Developing, proposing, coordinating and representing concepts for quality-assuring activity/improvement programs with/at suppliers and pursuing the implementation of executed measures
05/2007 10/2010
Detroit, MI
Supplier Quality Engineering
Detroit, MI
Supplier Quality Engineering
05/2007 10/2010
Detroit, MI
Supplier Quality Engineering
05/2007 10/2010
  • Maintain Supplier Performance Storyboard and champion Supplier Performance review for underperforming suppliers
  • Provide leadership in implementing Supplier Quality improvement and defect reduction plans
  • Drive Quarterly goals to meet objectives. Create & Maintain Performance KPI’s
  • Includes supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence
  • Own and Lead monthly Supplier Performance Reviews on Top poor performing Suppliers with monitoring of corrective action plans
  • Develop and maintain an open issues list along with a timing plan and report any concerns or issues to the core team
  • Develop and obtain Supplier approved boundary/PPAP samples and maintenance of the boundary samples throughout the production cycle
Education Education
Bachelor’s Degree in Mechanical
Bachelor’s Degree in Mechanical
Portland State University
Bachelor’s Degree in Mechanical
Skills Skills
  • Ability to analyze, troubleshoot and follow up on internal & customer supplier quality issues
  • Strong Technical Writing skills and proficiency in Technical Review of documents
  • Knowledge of basic concepts of design, metrology and instrumentation
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables
  • Ability to write routine reports and correspondence. Ability to communicate effectively with employees of organization
  • Measure and reporting of suppliers’ capability and quality performance
  • Knowledge of basic concepts of design output, metrology and instrumentation
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Self-Motivated, ability to initiate and follow tasks through to completion
  • Ability to troubleshoot and solve problems related to manufacturing
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1

Supplier Quality Engineering Manager Resume Examples & Samples

  • Bachelor degree or above, major in Engineering or related field
  • Minimum 10 year’s experience in supplier quality and/or quality engineering experiences
  • Must be a strong leader and excellent at applying quality monitoring and quality improvement techniques
  • Ability to travel 20%
  • Required to be fluent in English, both spoken and written
2

Supplier Quality Engineering Specialist Resume Examples & Samples

  • Evaluate and authorize manufacturing processes and packaging related to the CKD (Complete Knock-Down kit) logistic process, according to the corporate guidelines
  • Apply methods like DOE (Design of Experiment), 6 Sigma, CEP (Complex Event Processing), etc. to analyze the root causes of complaints. Define technical factors to be used in the Warranty Chargeback initiatives
  • Make proposals and manage the technical product/process improvements required for the brand
  • Recommend technical product improvements evaluating risks and potential chances to avoid quality manufacturing issues, by comparing similar parts assembly line and field development
  • Evaluate technical proposals (product and process) based on the information provided by simulations in the suppliers, in order to recommend new parts nominations that will grant the achievement of the timeline with the desired quality
  • Developing drafts/analysis reports for each project key point as management information (regarding quality and schedules)
  • 5-7 years of experience
  • BS Engineering or Quality related experience
  • International experience
  • Travel / Supplier visits will represent approx. 30% of the time
  • German and Spanish languages
  • Technical Knowledge of VW specifications/drawings
  • Knowledge of VW Group Systems
3

Supplier Quality Engineering Specialist Electric Resume Examples & Samples

  • Solve manufacturing and field complaints via monitoring and analysis of the quality problems, ensuring that the contingency and definitive measures are implemented assuring process stability and preventing these issues in the future
  • Evaluate the initial samples and/or engineering change requests looking for product specification compliance, assuring the planning timelines correspond to the pre-series production vehicles, start of production and serial projects of new products
  • Audit the product at the supplier and at the VW manufacturing line, making sure that it is specification compliant and the manufacturing process and quality can be granted
  • Apply methods like DOE, 6 Sigma, CEP, etc. to analyze the root causes of complaints
  • Define technical factors to be used in the Warranty Chargeback initiatives
  • Coordinate with the suppliers the follow-up of projects to achieve the quality requirements and the stability of the processes. Define action plans to implement the needed improvements, based on the results
  • Developing, proposing, coordinating and representing concepts for quality-assuring activity/improvement programs with/at suppliers and pursuing the implementation of executed measures
  • Developing drafts / analysis reports for each project key point as management information (regarding quality and schedules)
  • 5 -7 years experience
  • Strong understanding of quality systems and processes
  • Familiar with Manufacturing Processes
  • Travel and supplier visits will exceed 30%
  • Weekend travel depending on scheduling / problems
4

Supplier Quality Engineering Co-op Resume Examples & Samples

  • PPAP activities to support NPD and SPD
  • Design, develop, and/or implement gauging and test equipment to be used for receiving inspection
  • Implementation of risk management on new and/or chronic issue parts/suppliers; activities related to Root Cause and corrective action related to current product and warranty issues
  • Justification and supporting data for warranty cost recovery; support rework and field activities
  • Currently pursuing a four year degree within related field of study
  • Employment involves working 40 hours per week in areas related to field of study and project work
5

Advanced Supplier Quality Engineering Resume Examples & Samples

  • Perform supplier visitations/audits as deemed necessary
  • Review and analysis of supplier dimensional data from 1st piece layouts, gauge R&R and capability studies
  • Diploma or Degree required in related filed required
  • 7-10 years’ experience in a manufacturing environment required
  • Demonstrated proficiency in Computer applications (i.e. word, excel, power point etc.)
  • Effective communication (written & verbal) with various departments within Autosystems and with customer plant liaisons
6

Supplier Quality Engineering Resume Examples & Samples

  • Effective and timely communication with Suppliers on issues regarding their Product Quality
  • Conduct Supplier audits as required to ensure accuracy of their internal systems and processes following Magna’s Supplier Audit process (i.e. changes made from Engineering Changes, Corrective Actions or Process Changes
  • Participate in Continuous Improvement activities for production related to Supplier product
  • Lead effective closure to Supplier DMN’s through to disposition and financial re-numeration
  • Maintain supplier performance data in Supplyweb
  • Meet all commitments – confront and elevate issues timely
  • Bachelor / Master’s Degree in Electrical Engineering required
  • Licensed Professional Engineer an asset
  • Understanding of thermal management concepts and photometry of optoelectronics devices considered to be definite assets
  • Strong understanding of semiconductor devices and their characteristics
  • Ability to travel extensively (20-30%)
  • 5 years’ experience in electronics systems or applications, preferably LED based required
  • Ability to efficiently work in a fast paced team environment
  • Proficient in dimensional systems and analysis
  • Knowledge of basic concepts of design output, metrology and instrumentation
  • Able to travel and work flexible hours to accommodate international Suppliers and support Operations needs
  • Ability to troubleshoot and solve problems related to manufacturing
7

Supplier Quality Engineering Resume Examples & Samples

  • Works with Modatek personnel on Advanced Product Quality Planning, and with cross-functional teams on the development of new and existing components to meet critical customer deadlines
  • Implements new procedures and processes in prototype stages of product launches in compliance with customer specific requirements
  • Coordinates, prepares and implements new program fixture builds including cost, design, timing and quality to meet customer, and Modatek standards
  • Actively participates in the development of PFMEA’s
  • Develops appropriate key dimensional control points on new programs in conjunction with the project co-ordinator and/or customer
  • Liaises between customers, Q.A., Engineering, Manufacturing and suppliers
  • Develops and maintains Control Plan documentation and procedures
  • Plans and prepares PPAP submissions on new products and engineering changes to meet customer deadlines and customer specific requirements (PSO and Run @ Rate)
  • Coordinates customer events at Modatek and ensures professional long term relationships are met and maintained
  • Evaluates quality issues utilizing appropriate problem solving techniques
  • Maintains a high level of confidentiality while managing customer sensitive documents and data that drives process and product changes
  • Assists in TS 16949 implementation and compliance
  • Performs statistical studies, reports data and communicates to shop floor for customer problem resolution
  • Participates in plant wide continuous improvement projects
  • Adheres to Modatek’s Core Values: Integrity, Respect, Trust, Honesty, Fairness and Loyalty
  • Understands, promotes and lives by Magna’s philosophies and the Employee’s Charter
  • Post-secondary graduate with a technical degree, diploma or certificate in Quality Engineering
  • Three (3) years of automotive engineering experience with new program launches
  • Prior experience with ISO/TS 16949 processes
  • Prior experience with Advanced Product Quality Planning, Production Part Approval Process submissions, Geometric Dimensions & Tolerancing, Flow Diagrams, FMEA’s, Control Plans, Statistics, and fixture development based on part GD&T
  • Demonstrated ability to use basic measurement tools (height gauge, vernier, micrometer, bore gauge, indicator, etc)
  • Demonstrated ability to conduct root cause analysis using various problem solving techniques including Drill Deep, 8D, 5 Phase
  • Ability to communicate to all levels of plant personnel with ease
  • Good organizational, interpersonal and problem solving skills
  • Ability to coordinate and facilitate cross-functional team meetings
  • Ability to work to meet deadlines and multiple demands
  • Demonstrates the ability to work effectively in a team environment
  • Ability to work overtime to meet customer needs
  • You will be provided with up to date training & knowledge in current automation technology
  • Extended Health Benefits
  • Employee Profit Sharing Plan
  • Group RRSP with employer match
  • Educational reimbursement program
  • Team Member appreciation events
8

Supplier Quality Engineering Specialist Resume Examples & Samples

  • To insure all e-coat & sealer suppliers are in compliance with all OEM standards as called out by the Customer Specifics
  • Prepare documentation and provide support for new program, EC, part launches and process changes at Drive Automotive including PPAP, ISIR Control Plan, FMEA, IPC etc as it relates to supplier quality
  • Responsible to insure assigned supplier(s) base adhere to Drive Automotive’s corrective actions request (on time closures, repeat concerns, root cause, etc)
  • Conduct Site audit(s) to verify stability of supplied parts from suppliers is met
  • Ensure the quality dimensional stability of supplied parts is being met as per Drive Automotive Industries & customer requirements
  • Perform system audits to ensure acceptable quality levels are maintained and properly monitored through Drive SQA managements systems or SQM
  • Ability to work assigned shift with no interruptions to scheduled time
  • Competent understanding of metering devices which measure and yield data for ecoating processes and or sealer applications
  • ALL SQA Documentation, KOI’s, MDR’s, Supplier Control Plan & FMEA’s, Supplier site audit documentation, top 5 failure modes reports, and month end reports
  • 4 year degree (Mechanical Engineer or Chemical Engineer preferred) and/or work history of 5-10 years of related work experience in an Ecoating/Sealer and Paint manufacturing or sales environment
  • Team Oriented Problem Solving (TOPS)
  • TS: 16949 internal external auditor
9

Lead Supplier Quality Engineering Specialist Resume Examples & Samples

  • Responsible for developing comprehensive quality assurance plan and quality control for the commodities procured for various water and waste water treatment projects. Commodities include fabricated tanks, Pressure vessels, heat exchanges, piping, skids, Valves, Pumps, Blowers, and Instruments, etc
  • Responsible for new supplier quality compliance audits and qualifications. EHS compliance for new as well as current supplier base
  • Responsible for current supplier quality process improvement and development
  • Responsible for resolving supplier quality issues, managing the suppliers to meet/exceed GE quality requirements, solving product quality issues through effective corrective & preventive measures, communicating to cross-functional teams
  • Building up effective and solid communication channels with suppliers as well as GE cross-functional team to ensure quality, on-time execution and delivery of equipment
  • Proactively looking for material cost out opportunities, developing supplier productivity projects by partnering with Engineering & Project teams
  • Candidate shall have bachelor’s degree in a technical discipline (preferably mechanical or Electrical engineering) with a minimum 5 years of vendor quality experience. Desirable to have Post Graduate Degree in Engineering discipline
  • Experience in Quality assurance and Quality control of fabricated components like Pressure vessels, piping, Skids, Heat exchangers etc
  • Preferable to have Welding inspector certification, NDT Level II certification in Dye Penetration test, Radiography test
  • Shall have knowledge on standards like ASME, ASNT, API, etc
  • Shall have knowledge on various metallurgies like SS, Duplex, super duplex, Titanium etc
  • Shall have expertise on inspecting Surface preparation and coating, Rubber lining, FRP components, PVC piping etc
  • Candidates shall have strong interpersonal skills to effectively communicate and interact with customers and suppliers on a technical level
  • Lean Six Sigma Green Belt certified or Experience
  • Preferable to have exposure in Water & Waste water treatment commodities
  • Knowledge and understanding of ISO 9001:2000 Quality Management Systems and ISO 14001 Environmental Management Systems
10

Supplier Quality Engineering Resume Examples & Samples

  • Includes both Supplier Quality Assurance and Supplier Quality Development
  • Assess supplier capabilities and make recommendations on supplier acceptability
  • Understand strategies for assigned commodities & proactively drive initiatives to meet Sourcing objectives
  • Analyze and track Supplier promise date accuracy and develop reports to ensure Supplier promise date accuracy
  • Support commodity buys. Writes reports to track PO activity and supplier performance
  • Communicates with direct team and supervisor
  • Presents to internal teams on metrics, project status and research
  • Elaborates proposals for improvement in approaches, methods, procedures and processes in the own field
  • Contributes to project as a team member
  • Bachelor's degree from an accredited university or college or equivalent knowledge and experience (or a high school diploma / GED with demonstrable competence gained in Sourcing or Quality
11

Lead Supplier Quality Engineering Resume Examples & Samples

  • Includes supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence
  • SQEs have various levels of differentiation which are related to level of technical understanding of engineering drawings and ability to manage vendors
  • Works together with high level people from the business at SPB and EB level
  • Specifies needs, communicates about project approach and presents outcomes of research done
  • Actively participate in supplier performance reviews
  • Advises Functional managers regarding projects, processes and procedures in the own field
  • Contributes to project as a team member or leads small projects
  • Bachelor's degree from an accredited university or college or equivalent knowledge and experience (or a high school diploma / GED with demonstrable competence gained in Sourcing or Quality)
  • Extensive knowledge of Supplier Quality Engineering
  • Ability to influence others and lead small teams
  • Proven analytical and organizational ability
12

Manager Supplier Quality Engineering Resume Examples & Samples

  • Overall responsibility for software suppliers’ quality management i.e. Harman Standard SW Supplier Quality Engineering Process (ACQ.15) and supporting implementation of Supplier Monitoring Process (ACQ.4)
  • Develop high level annual plan aligned with business needs and revisiting frequently based on changes
  • Identify and consolidate software supplier data involved in different HARMAN projects
  • Conduct workshops with internal stakeholders to analyze supplier collaboration model, process and product quality to create and maintain supplier ranking
  • Plan activities needed to determine suppliers’ process capabilities e.g. through SW Quality workshop or assessment aligned with business priorities
  • Organize and execute Supplier assessments (onsite/offsite) using AutomotiveSPICE as yardstick to analyze gaps in development processes, process artifacts and work products
  • Review and rate process improvement activities of suppliers in parallel to tracking and reporting progress
  • Identify and report suppliers’ competence according to process and product quality
  • Strong involvement in Supplier selection, approval and blocking process
  • At least Bachelor degree in electrical engineering, computer science or equivalent technical education
  • 3-5 years of experience in embedded software design or development
  • AutomotiveSPICE competent assessor (VDA certified), with assessment experience and experience in process improvement (HIS-Scope Level 3 and / or CMMI-DEV)
  • Very good knowledge about further industry standards like CMMI, ISO 9001, TL 9000, ISO / IEC 15504, TestSPICE
  • Ability to map identified weaknesses to inherent process issues and definition of remedies
  • Skills for effectively managing Software SQE function with globally distributed counter-parts
  • German and English (business fluent)
13

Director of Supplier Quality Engineering Metals Category Lead Resume Examples & Samples

  • Act as subject matter expert (SME) for MD&D Supplier Quality as it pertains to Metals suppliers
  • Create network of Metals supplier quality engineers across MD&D and lead council or similar type process
  • Develop and implement across MD&D standardized best practices for MD&D Metals suppliers in the areas of (but not limited to) component qualification and validation, process control, quality agreements and CTQ Cascade that are in alignment with MD&D Supplier Quality Standards
  • Work closely with MD&D & J&J Metals Category Leaders (procurement) to provide input to long term Metals strategy from a supplier quality perspective and participate in strategic supplier business reviews
  • Work closely with MD&D Partner Development and Sustaining Engineering on improvements with strategic Metals suppliers
  • Participate in Metals supplier assessments and aid in close out of franchise and sector wide improvements with common solutions where appropriate utilizing Lean and Six Sigma methodologies
  • Assess different elements of supplier quality data relative to Metals suppliers (e.g. quality systems audits, supplier assessments, internal audits, complaints, field actions, external audits at Metals supplier, etc.), identify areas of improvement and create initiatives to implement them
  • Partners with Enterprise and Franchise functions to ensure appropriate services to support Metals Supplier Quality needs
  • Partners with the respective management for their sphere of influence to develop and support initiatives and responses to quality risks and threats
  • Ability to share knowledge and influence colleagues in other disciplines at senior levels of the organization and be able to work across all of MD&D
  • Ability to execute complex, multidisciplinary technical projects and understands the interrelationship among quality functions and with other business functions
  • Ability to influence business and strategic directions
  • Collaboration & Teaming
  • Results & Performance Driven
  • Self Awareness & Adaptability
  • Big Picture Orientation
  • Minimum BS in engineering, technical or supply chain disciplines required
  • MS or higher is highly preferred
  • Minimum of at least 10 years of supply chain and/or quality experience
  • Technical expert through contributions to technical peer-reviewed journals, or leader of technical committee, or active participation in technical / professional societies (also can consider invitations to lecture, notated as contributing to literature, or scientific/technical awards) preferred
  • Has technical achievements that prove critical to the development of a new process and/or product
  • Prior experience working with Metals suppliers is preferred
  • Process Excellence Green Belt/Black Belt Certification (Six Sigma or Lean) or equivalent is highly preferred
  • Project Management Certification preferred
  • ASQ Certification is preferred. Experience working in regulated industries is required. Experience in Medical Device industry is highly preferred
  • This position can be located in the Greater Boston area or any JNJ Location in New Jersey
  • This position will require 30-40% Travel
14

Supplier Quality Engineering Manager Resume Examples & Samples

  • Bachelor’s Degree in engineering
  • 7+ years of experience in the medical device industry or highly regulated industry
  • 5+ years of experience in Supplier Quality
  • 10+ years of experience in the medical industry or highly regulated industry
  • Experience managing people (leadership skills)
  • Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Oral and Written communication skills
  • Ability to work & lead a team/partnership environment
  • Computer Skills (Microsoft - Word, Excel, Project, PowerPoint)
  • Lean Sigma skill set
15

Manager, Supplier Quality Engineering Resume Examples & Samples

  • Ensure continuous quality compliance through quality improvement program for the Stryker supplier base
  • Leverage greater efficiencies in the supplier compliance group by developing and applying global standardised/harmonised methodologies to quality activity management and ensure tactical execution at the manufacturing sites
  • Identify areas of opportunity and support continual improvement of Quality and work with the relevant groups on how these can be improved
  • Collaborate with the co-ordination of external body audit activities at the manufacturing sites as pertains to supplier interaction
  • Create and foster a strong working relationship with the different Global Supplier Quality functions, Global Quality, Strategic Sourcing and additional key interfaces to facilitate effective collaboration
  • Actively develop the team’s expertise and team dynamics through continuous coaching, promoting development programs and formal appraisals through the review process
  • Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously
  • Highly developed problem solving skills
  • Demonstrated ability to lead cross-functional teams
  • Computer literacy
  • Travel required up to 50%-75%
16

Display Manufacturing Supplier Quality Engineering Manager Resume Examples & Samples

  • Strong understanding of manufacturing for tight cosmetic requirements
  • Demonstrated ability to hire, mentor and lead talent
  • Exceptional communication skills - verbal, written and presentations
  • Ability to easily present complex situations / data and articulate effectively to senior executives. High level of ‘exec presence’ necessary
  • Preferred: OLED process experience and / or flexible display module process experience
  • Periodic travel required (up to 30%)
17

Supplier Quality Engineering Resume Examples & Samples

  • Manage the part qualification process for assigned suppliers
  • Manage activities that define, deploy and survey supplier quality requirements including qualifications, action plans, audits, and performance monitoring
  • Engineering degree from an accredited university or college or equivalent knowledge and experience
  • Proven years of experience in Supplier Quality Assurance within an Automotive or Aviation environment
  • Supplier audit experience
  • Strong interpersonal skills with ability to build and form relationships and work cross functionally across the business matrix
  • Self motivated, high energy with an ability to work independently
  • Proven analytical and organisational capability
18

Lead Supplier Quality Engineering Resume Examples & Samples

  • Includes supplier qualifications, action plans, audits, performance monitoring, and assisting key suppliers towards industrial standards of excellence. SQEs have various levels of differentiation which are related to level of technical understanding of engineering drawings and ability to manage vendors
  • Advises Functional managers or other Functions regarding approaches, processes and procedures in the own field
  • Manage and drive complex suppliers and escalation of poor performing or uncooperative suppliers
  • Drive and execute strategic improvements within the supplier quality organization
  • Analyze, track and drive supplier issues to achieve robust problem resolution in a timely manner
  • Work with allocated key suppliers to improve quality statistics to target levels
  • Ability to analyze and drive efficiency and reduction of non value added activities within the business
  • Supplier audit experience of AS9100/AS9102 & S1005/S1007
  • Self-motivated, high energy with an ability to work independently
19

Senior Supplier Quality Engineering Manager Resume Examples & Samples

  • Support quality-driven supplier selection, development, and monitoring and overall supplier management in accordance with the broader GE Water & Distributed Power sourcing strategy
  • Manage SQE resources to provide technical guidance to the Chinese supplier base and ensure product and process compliance with engineering drawings and specifications
  • Monitor supplier non-conformance performance, drive root-cause analyses, corrective actions and process improvements to reduce the Number of Defects and Cost of Quality
  • Establish a structured approach to improve quality assurance and drive consistency and adherence to quality procedures
  • Manage effectively the travelling budget of the team: balance supplier surveillance audits and technical inspections to mitigate quality risks with supplier development activities to accelerate qualification projects
  • Strong participation in annual operations planning
  • Demonstrated leadership and organizational skills (>5years people management)
  • Process analysis, problem solving, and strategy development skills
  • Highly motivated
  • Fluent in English & Mandarin
  • Demonstrated technical aptitude in electrical engineering and a passion for quality
  • GE program graduate is preferred (GE employees only)
  • Ability to travel 50% of the time
20

Lead-supplier Quality Engineering Resume Examples & Samples

  • On-time execution of New Component Introduction (PPAP) projects
  • Drive & ensure compliance to supplier facing processes (Audits, PPAP, CARs, SDRs, etc)
  • Identify & qualify new products & suppliers in the region to drive growth
  • Develop positive relationships and work closely with Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions etc
  • Audits (Process, Product, Quality systems, SRG/Compliance, 'Eyes always Open'): Obtain a sound understanding of GE expectations on audits. Conduct audits in keeping with good practices & publish professional reports in the appropriate system. Identify & communicate best practices/risks Work with supplier & other stakeholders to close findings & improve supplier processes
  • Problem-solving: Monitor Defects/DMRs'/Feedback for suppliers to identify any existing problems Use DMAIC methodology to identify & eliminate root cause sustainably on appropriate system
  • Machining: Processing parts using conventional & modern equipment
  • Non-metallic products
  • Strong spoken and written English communications skills
  • Strong PC and data management skills
  • Knowledge of destructive & non-destructive testing methods in all of the above areas
  • Candidates with certifications in technology, quality systems, audit or testing areas can be preferred based on relevance of certification
21

Supplier Quality Engineering Intern Resume Examples & Samples

  • Completion of sophomore year at an accredited university by summer of 2017
  • Pursuing a Bachelor of Science degree in Mechanical Engineering, Electrical Engineering, Aerospace/Aeronautical, Biomedical/Biomechanical/Bioengineering, Chemical, Materials, Metallurgical, or Mechatronics from an ABET accredited university
  • Willingness to travel 20-40%
  • Strong interest in the automotive industry and new technologies
  • Computer proficient in Excel and other Microsoft Office applications
  • Creative problem solving ability and a results orientation
  • Ability to travel within NAFTA region (potential)
  • Reliable personal vehicle
22

Senior Supplier Quality Engineering Manager Resume Examples & Samples

  • Bachelor’s Degree in Engineering or Science and 7+ years of technical experience in a Quality function
  • OR Master’s Degree in Engineering or Science 5+ years with a of technical experience in a Quality function
  • 5+ years of progressive leadership experience in functional area
  • 5+ years of experience in medical devices
  • 5+ years related SQA or Sourcing experience. MBA/MS degree in science or engineering
  • Experience with DOE, MSA, Process Capability, SPC, Gage R&R
  • Program Management experience and/or Lean Sigma skill set
  • Manufacturing process knowledge / experience including: injection molding, extrusions, machining and electronics
  • Ability to attract, develop, and retain diverse talent
  • Innovation: Contributes innovative ideas that lead to positive business results encouraging and adopting new ways of looking at problems, processes and solutions
  • Strong Oral and Written communication skills
  • Ability to work & lead a team independently
  • Strong Computer Skills (Microsoft- Word, Excel, Project, PowerPoint, Visio)
  • Six Sigma and/or Lean knowledge
  • Quality System Lead Auditor experience (ISO 13485)
  • Significant manufacturing & supplier controls experience in multiple areas
  • A working knowledge of the following: FDA 21CFR820; Quality System Regulation; ISO 13485; ISO 14971
23

Supplier Quality Engineering Team Leader Resume Examples & Samples

  • Provides quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products
  • Conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards
  • Report on contract manufacturer performance metrics and management reviews
  • Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus
  • The Team Leader Supplier Quality will provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards focus. The Team Leader Supplier Quality will have leadership responsibilities within the group and will help manage and direct the work of other Quality Engineers
  • A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline
  • A minimum of 5+ years of experience in a highly regulated industry is required. Supervisory experience preferred
  • Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry is an asset
  • Strong in root cause analysis skills required
  • Experience or knowledge with machining manufacturing processes and injection molding an asset
  • The ability to direct a team in meeting departmental goals and objectives, make effective oral and written presentations, to prioritize and manage multiple projects consisting of varying degrees of complexity and to analyze complex problems and apply practical solutions will be needed
  • This position will require up to 25% travel.Quality (Eng)
24

Manager, Supplier Quality Engineering Resume Examples & Samples

  • 10+ years of relevant quality engineering, supplier quality management, quality systems development
  • Be a demonstrated change agent who excels in a team environment, is customer focused and able to consistently meet commitments
  • Knowledgeable of supplier quality management methods and quality system requirements
  • Excellent management and problem solving ability, understanding the application of statistical techniques and highly developed skills in oral and written communication
  • Global supplier audit experience and familiarity with multiple manufacturing technologies
  • Previous supervisory experience is highly preferred
  • ASQ recognition as a Certified Manager of Quality/Organizational Excellence and/or Certified Quality Engineer is highly desirable
25

Lead Supplier Quality Engineering Specialist Resume Examples & Samples

  • Provide leadership to drive growth in business cooperation between GE and supplier base
  • Act as the technical focal point for Casting supplier activities directed toward process control and quality assurance of business components
  • Work closely with various divisions of Transportation businesses to conduct First Piece Qualification (FPQ), quality surveillance, and audits
  • Lead the supplier part approval (PPAP) process including manufacturing, technology, and Environmental Health and Safety (EHS) risk analysis
  • Drive continuous improvement of supplier's quality, and delivery performance through Six Sigma
  • Work closely with Sourcing, Manufacturing, and Engineering to eliminate roadblocks and communication barriers that may affect quality and delivery requirements
  • Bachelor's degree from an accredited university or college
  • 4+ years of experience in a Sourcing Quality and Quality role
  • 4+ years of Casting quality experience; or minimum 8 years of Castings quality and manufacturing experience
  • Willingness and ability to travel as necessary
  • Prior experience in interpretation of blueprints / specifications, metrology, and manufacturing process planning / evaluation
  • Six Sigma training is preferred
26

Manager, Supplier Quality Engineering Resume Examples & Samples

  • Overall responsibility for software suppliers’ quality management i.e. Harman Standard SW Supplier Quality Engineering Process (ACQ. 15) and supporting implementation of Supplier Monitoring Process (ACQ. 4)
  • Bachelor degree in electrical engineering, computer science or equivalent technical education
  • 5+ years of experience in embedded software design or development
  • HARMAN products and project experience i.e. development and / or line management
  • Skills for effectively managing SW SQE function with globally distributed counter-parts which partners with geographically distributed multiple engineering teams working on multiple programs to ensure high quality based on SW delivery experiences
  • Understanding of business requirements and technical implementation of distributed services and demonstrated ability to collaborate with QA counterparts in other geographies to develop effective QA strategies tracked by meaningful metrics
  • Knowledge about Supplier Quality methodologies and tools
  • English (business fluent)
  • Willigness to travel
  • AutomotiveSPICE competent assessor (VDA certified), with at least 300h of assessment experience and 3-5 years of experience in process improvement (HIS-Scope Level 3 and/or CMMI-DEV)
  • Very good knowledge about further industry standards like CMMI, ISO 9001, TL 9000, ISO/IEC 15504, TestSPICE
27

Supplier Quality Engineering Manager Resume Examples & Samples

  • Leads new supplier based industrialization projects for product or product parts from inception through shipment to customer
  • Accountable for establishing requirements and reviewing vendor infrastructures, in both technological and rate capacity, to insure that they will be able to provide products that meet with emerging and existing technologies as required per new developing products or manufacturing improvements to current products
  • Evaluates and coordinates engineering change requests from vendors and processes with the engineering department & Industrialization until issues have been resolved
  • Reviews suppliers deliverables at all stages of development and will ensure product or product parts can be manufactured, inspected and are repeatable at specified supplier's sites. This may include identifying special tools; providing special design tools/fixtures, and processing manufacturing instructions at stated sites
  • Leads teams in System Failure Analysis & Process Failure Mode Effects Analysis. Identification of root causes, developing and implementing corrective actions, ensures corrective action is effective and efficient, and trains personnel to effect corrective action
  • Perform research and/or testing for development of new vendors or technology
  • May work with other Zodiac business units on joint design or industrialization projects or proposals
  • Actively seeks out new sources of supply and presents report on future projects ROI
  • Bachelor's Degree in Engineering (or equivalent) from a recognized institution
  • Minimum 4 years' experience in problem solving methodologies used in determining root cause and formulating corrective action(s) - i.e. thought maps, 8D, root cause analysis, Process Failure Mode Effect Analysis, control charts, Pareto charts, etc
  • Desired Master's degree from a recognized institution in an engineering science such as (but not limited to) Mechanical, Electrical, Manufacturing, etc.
  • Desired minimum of 4 years of engineering experience in the manufacturing and development of aircraft components and/or systems and experience leading technical team(s)
  • Desired minimum understanding of manufacturing principles and technical specifications to support facilities and supplier competencies – i.e. machining and manufacturing processes, tool design, injection molding, welding, soldering, plating, painting, die cast molding, etc
  • Familiarity with ASME Y14 drawing practices including GD&T and PDM/PLM tools
28

Supplier Quality Engineering Resume Examples & Samples

  • 7 years experience in supplier quality engineering work with OSATs
  • Experience with assembly and test subcontractor management including addressing and follow up on quality issues and process improvement initiatives
  • Thorough understanding of reliability testing and failure analysis
  • A good understanding of wafer fabrication or substrate process are plus
  • Good communication and interpersonal skills. Able to work independently while still being a team player in cross functional teams located in Asia and the United States
  • Fluent in Mandarin Chinese and English
  • Flexible to travel domestically and internationally
29

Senior Manager, Supplier Quality Engineering Resume Examples & Samples

  • Responsible for all aspects of supplier quality from development through end of life for Harman Professional Solutions Europe
  • Develop processes to assure smooth interaction between Harman Professional North American and / or European locations and the Harman Professional China Supplier Quality organization. Assuring cohesive information and KPIs
  • Defines development and quality procedures to be used internally and externally. Works with all Harman International organizations to assure continuity of procedures
  • Establish supplier audit plan as well as set up KPIs and expectation on the quality side to support Procurement and Product Sourcing on negotiations and NPIs
  • Support FAIRs on NPI and resources activities from a supplier quality prospective
  • Support supplier development working with Harman Procurement and Product Sourcing
  • Applies Advanced Quality Planning techniques such as Failure Mode Effects Analysis, control plans, and measurement system analysis to evaluate the internal and external manufacturing ability to produce products with a stable process
  • Develops systems for recording and analyzing product quality levels. Interprets and reports trends and improvement plans. Responsible for KPIs such as or similar to PPM and failure rates
  • Supports QBRs with supplier , product sourcing, quality and Harman procurement
  • Develops training programs in activities of Quality (i.e. SPC, problem solving, and Advanced Quality Planning). Trains external and internal groups as required
  • Foster a positive team environment and interact cross functionally with design engineering, NPI, purchasing, marketing, and sales. Interact with external subcontracting sources
  • Bachelor’s Degree in Engineering
  • 7-10+ years of Experience in Supplier Quality, Quality Engineering, Business Management or a related field
  • At least , and 7+ years of QMS
  • Demonstrated experience in problem solving, supplier quality, and quality management
  • Ability to implement strategies to control the company’s supplier quality and supplier development to assure an adequate source of service and supply. Manage supplier’s quality performance
  • Knowledge and participation in Six Sigma activities, including participation in Kaizen, Value Stream Mapping (VSM) and other continuous improvement activities. As well as knowledge on project management
  • Excellent verbal, organization and written communication skills
  • Experience working with process improvement methodologies
  • Proficient in computer use (MS Word, Excel, Project, Outlook and SAP)
  • Ability to work in a metrics-driven, fast-paced and dynamic environment
  • Proactive and aggressive in solving problems, recognizing and taking action on opportunities and developing a team environment to understand and execute company-wide needs in regards to material supply
  • Maintain and promote sound relationships with internal customers, suppliers and business community
  • Ability to work with cross-functional global team
  • Ability to handle a variety of projects at the same time
  • Ability to develop and populate reports, business correspondence and procedure manuals
  • Ability to effectively present information and respond to questions from groups of managers, vendors, customers, and company employees. Ensure communication with business owners is consistent, clear, timely, helpful and productive
30

Supplier Quality Engineering Specialist Resume Examples & Samples

  • Contributing to growth plans with existing & new suppliers
  • Working in a boundary-less manner with diverse global teams to achieve the
  • Accurate & rigorous evaluation of current and potential suppliers using multiple tools
  • Maintain & upgrade product & process quality at suppliers
  • Collaborate with other functions as required to execute PPAP projects
  • Participate in planning of supplier quality activities, share knowledge with team, training, etc
  • Fabrication: Light to heavy steel fabrication including welding
  • Strong understanding of quality tools used to manage supplier quality
  • Strong interpersonal, team-work & and leadership skills
  • Proven project management and process improvement ability
  • Change agent with the ability to influence at multiple levels of the organization across functions
  • Prior work experience in a similar work environment
  • Six Sigma Green Belt or Black Belt certification is preferred (GE Employees only)
31

Supplier Quality Engineering Resume Examples & Samples

  • Forms a good relationship with the purchasing engineer and the supplier system in order to maintain a strong support system and supplier relationships for the organization in which they work
  • Ensures supplier selection, development, approval and rejection according to SJM vendor guidelines and requirements
  • Leads supplier process capability studies
  • Constructs Design of Experiments to characterize supplier processes and/or determine root cause
  • Develops and implements procedures for new and/or improved supplier processes
  • Provides engineering support to Receiving Inspection including statistical analysis, measurement systems analysis, Gage R&R studies and inspection procedures
  • Use of the following tools may be required
  • Electronic Assembly: color code, component, schematics. May require various
  • Inspection: bare board, systems, components, cable and harness, microscope, measuring tools. Mechanical & Electrical Tools: taps and dies, alignment tools, measuring tools. Office skills: telephones, data entry, office software to include, word processing, spreadsheet and presentation package
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
  • Ability to define problems, collect data, establish facts and draw valid conclusions
32

Supplier Quality Engineering Internship Resume Examples & Samples

  • Train and utilize ERP systems for data mining, including Trackwise, Master control, E1 and SAP
  • Coordinate Questionnaires with Suppliers and internal team members
  • Develop metrics to support Supplier Scorecards
  • Update Supplier Audit Schedule
  • Optimize Forms and SOPs for Supplier Quality.Perform Supply Chain Risk assessment data input utilizing Systems and forms. Collaborates with Procurement, R&D and Operations to effectively as assigned for Risk Mitigation Plans and activities to support continuous improvement projects
  • Develop Risk Mitigation Action Plans through collaboration with various internal teams
  • Operate job duties according to procedures and supports Global Supplier Quality Team members as needed
  • Collaborates with the Procurement team assigned to support supplied products and materials. Aligns with Purchasing to report supplier performance
  • Support as needed the Material Review Board meetings, Supplier Review Board meetings and other critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness
33

Supplier Quality Engineering Resume Examples & Samples

  • Ensure Supplier Quality Systems are compliant to ISO 9000, TS16949 and Autosystems Supplier Manual
  • Perform audits on incoming material and review and maintain material certifications
  • Manage all Supplier quality issues through implementation and verification of short and long term corrective actions including management of containment activities both internal and external
  • Work closely with Materials Department on supplier delivery issues
  • Support suppliers through the PPSR process and report out on supplier issues at the fast response meeting
  • Ensure Best Practices are followed throughout the Design Process
  • Conduct Supplier audits, as required with both Domestic and International travel up to 25% on the time
  • Maintain Supplier Performance Storyboard and champion Supplier Performance review for underperforming suppliers
  • Drive product improvement/continuous improvement activities at Suppliers (cost and durability)
  • Responsible for accuracy and timely completion of all quality documentation (i.e. quality alerts, process flow, PFMEA, Control Plans, PSO & PPAP)
  • Participate in PDT Meetings as required in regards to design and specifications required
  • Develop and monitor with the Quality Engineer, Product Engineer and Program Manager the overall dimensional plan for the program GD&T, # of measurement points, datum scheme, # of components to be measured at various stages of the program etc
  • Develop and maintain an open issues list along with a timing plan and report any concerns or issues to the core team
  • Timely closure of Engineering Change action items
  • Ensure Supplier representation / resources are in place for launch programs as deemed necessary
  • Responsible for review and timely approval of all Supplier PPAP, ensuring all elements and deliverables are met
  • Support the shop floor with training, and documentation as required
  • Understand all performance and engineering specifications applied to the parts
  • Ensure the timely receipt of accurate, in spec. certifications and testing documentation
  • Disposition purchased component accumulated rejects as to Supplier or Autosystem's responsibility
  • Issue DMN's as needed and maintain DMN reporting systems, contact the supplier for RMA's as required, file corrective actions as established and document quality improvements
  • Responsible to verify and support correcting Supplier IMDS submissions
  • Review Warranty returns, follow up communications with customers and provide analysis of data as required
  • Any projects as assigned by Management
  • Diploma or Degree in a mechanical/ manufacturing or electrical field would be an asset
  • CQE Designation would be an asset
  • Grade 12 Diploma or equivalent education required
  • Valid driver’s license required
  • Good understanding of TS16949, ISO 9000 & IMDS
  • Knowledge of various processes (i.e. Moulding, Coating, Assembly etc.)
  • Knowledge of basic concepts of design, metrology and instrumentation
  • Strong computer skills, including Microsoft Office and other software applications
  • Self-starter with the ability to prioritize many different tasks
  • Effective English verbal and written communication skills
  • Ability to gather and analyze information
  • Ability to work independently and also as part of a team to gather an analyze information
  • Ability to work with a high degree of accuracy and attention to detail
34

Lead Supplier Quality Engineering Resume Examples & Samples

  • Conduct Supplier Audits/Surveillance for Conformance - Technical, QMS and Environmental Health and Safety
  • Establish a structured approach for quality assurance and drive consistency and adherence to quality procedures and requirements
  • Provide technical guidance to suppliers toward assuring product/process compliance with engineering drawings and specifications
  • Lead Part Qualification Team Activities, Primary Interface with the Supplier throughout the qualification process. Milestone Plan and inform Businesses of Changes and Delays in Schedule. Perform in-process checks during part qualification as required
  • Work closely with Sourcing COE's, business teams, Manufacturing, and Engineering to eliminate roadblocks and communication barriers that may affect quality and delivery requirements
  • Drive continuous improvement of supplier's quality, cycle, and delivery performance through Six Sigma
  • Define Qualification Requirements and communicate them to Supplier, working with Sourcing and Engineering team
  • Conduct pre-qualification meeting with the supplier to review requirements, and resolve open issues
  • Coach Supplier in preparation of Manufacturing Process Plan (MPP), Review, approves and validates the same
  • Manage Sample and Production part Inspection on materials / equipment
  • Work with supplier on root cause analysis and corrective action implementation. Monitor Corrective Action Implementation at Supplier to Resolve any Deficiencies identified by the Audits/product NC
  • Assure supplier is complying with CTQ specification requirements for process capability data analysis
  • Monitor Supplier's Sub-supplier management process Assure all sub-suppliers performing special processes are qualified
  • Bachelor's degree in Engineering from an accredited university or college (or equivalent knowledge/experience),
  • Proven experience in Supplier Quality Engineering,
  • Ability and willingness to travel extensively
  • Experience with Motors, rotors manufacturing would be a plus,
  • Analytical and problem solving skills,
  • Ability to work in cross functional team environment,
  • Strong written and verbal communication skills,
  • ISO 9001 Auditor experience,
  • Supplier management and Sourcing experience,
  • Six Sigma certified (Green Belt a must),
  • Quality and process control experience,
  • Familiar with interpretation of engineering drawings / specifications and manufacturing process evaluation,
  • Ability to work in cross-functional, global team environment
35

Manager Supplier Quality Engineering Resume Examples & Samples

  • Recruits, coaches and develops organizational talent
  • Creates an entrepreneurial environment
  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments
  • Develops, monitors and appropriately adjusts the annual budget for department(s)
  • Medical Device experience is preferred
36

Senior Manager, Supplier Quality Engineering Resume Examples & Samples

  • Overall responsibility for global supplier development at EMS (Electronics Manufacturing Service / Outsourcing) partners
  • Manage a team of global SQE EMS Engineers to perform site assessment and other activities in connection with launching new programs at EMS suppliers
  • Clearly define and setup processes for QMS audits and Production Process audits based on industry standards such as VDA 6.3; TS 16949 and CQI
  • Once the processes are implemented then ensure team is fully trained and it understands and follows the processes as defined
  • Monitor all relevant KPIs and work towards improvements on the targets and actuals
  • EMS site assessments based on VDA 6.3 and CQI-17
  • Using the Audit results work closely with the EMS suppliers ensure the continuous improvement and closing of the open issues
  • Coach and lead a team of SQE Engineeers to ensure that they work closely with all stake holders internal and external to setup the new processes and production lines at EMS suppliers
  • Be the “Go To” person for all issues that may arise during the transfer or NPI program launch at EMS
  • Plan and execute a closed loop action plan to prepare and get the EMS site/s ready for OEM customer audits
  • Plan activities needed to determine suppliers’ process capabilities e.g. through Quality workshop or assessment aligned with business priorities
  • Organize and execute Supplier assessments (onsite/offsite) using Quality tools as yardstick to analyze gaps in development processes, process artifacts and work products
  • Propose process improvements and corrective actions depending on the project or product to improve overall HARMAN product quality and lock them into process improvement roadmap
  • Lead, contribute and track supplier development according to process improvement roadmap
  • Escalate issues adequately and effectively
  • Define, review and rate suppliers’ artifacts to ensure effective supplier monitoring
  • At least Bachelor degree in Electrical / Electronics or Mechanical engineering,computer science or equivalent technical education
  • Trained VDA 6.3 auditor or Lead Auditor will be a plus
  • Very good knowledge about Automotive industry standards like IATF 16949, VDA6.3, CQI etc
  • Minimum 10 years of experience in Quality Assurance or Supplier Development in Automotive industry with a Global player
  • Experience in Automotive Electronics Manufacturing is a must
  • Knowledge about Supplier Quality Engineering methodologies and tools
  • Team leader experience and strong leadership skills with very good communication skills
  • English (business fluent) is a must. Any additional language skills in Hungarian, German, Spanish or Romanian can be a plus
37

Supplier Quality Engineering Resume Examples & Samples

  • Minimum of 3 years of experience in Supplier Quality Assurance and/or Quality Management Systems including auditing experience
  • Bachelor's Degree in Mechanical Engineering
  • Excellent analytical and problem solving skills, strong background in metrology and applying statistical quality control tools for process / product controls, such as SPC, gage R&R, FMEA and DOE
  • Ability of interpretation of engineering standards, drawings / specifications
  • Demonstrated ability to handle diverse
  • Activities simultaneously, ability to work cross-functionally and interface different teams, functions, sites
  • Demonstrated energy and project management skills
  • Six Sigma GB or BB Certified or equivelant Quality certification (GE Employees only)
  • Strong experience in plastics molding, metal fabrication, machining, stamping, and finishing – with emphasis on process evaluation and quality assurance
  • Experience with 3D modeling
38

Supplier Quality Engineering Resume Examples & Samples

  • Be responsible for development and maintenance of an effective and robust Purchasing Controls and Supplier Management / Quality System ensuring consistent application of medical device regulations across IDM and DDR&D
  • Support GMP compliance, Pre-Approval and General Inspections by various regulatory agencies, notified bodies, and internal audits
  • Perform internal assessments and external audits on an as needed basis to support IDM, DDR&D, and CMOs
  • Provide leadership, guidance, and consultation on Quality Standard/Regulations, Quality Systems, and Quality Issues surrounding the Quality Management System including yet not limited to supplier management, investigations, deviations, change controls, procedures, and device master record development and revisions, validations, and batch dispositions
  • Bachelor’s Degree in Science or Engineering
  • Minimum of five (5) years industry related experience in quality roles supporting medical device manufacturing or equivalent (automotive, aerospace, consumer goods)
  • Minimum of three (3) years industry related experience Supplier Quality Assurance / Purchasing Controls Management
  • Experience with ISO9001 and / or ISO13485
  • Problem Solving and Decision-Making skills, with emphasis on Data-Based Decisions, and Customer Service
  • Strong Technical Writing skills and proficiency in Technical Review of documents
  • Minimum of seven (7) years industry related experience in Quality Assurance
  • Minimum of three (3) years industry related experience in performing internal and/or supplier audits
  • Knowledge and experience with Regulatory Requirements (e.g., 21CFR Parts 4, 11, 210 and 211, 820, 803, and 806; ISO 14971; Canadian MDR; EU Medical Device Directive/Regulation; JPAL; and other country specific MOH regulations)
  • Experience in negotiating Quality/Service Agreements
  • Experience in Process Validations supporting Injection Molding and / or High Speed Assembly
  • Experience with mechanical and / or electro-mechanical medical device manufacturing
  • Lean process experience
  • Demonstrated Teamwork and Interpersonal skills with internal and external partners
  • Strong Administrative and Organization skills
  • Demonstrated ability to influence others without authority
  • Ability to influence diverse groups
  • Ability to work independently with a high degree of ownership and accountability
  • Ability to multi-task and work under ambiguous situations
  • Experience with applications such as Trackwise, Regulus, SAP, and Microsoft Office applications
39

Supplier Quality Engineering Manager Resume Examples & Samples

  • 1) Collects and understands external and internal customers’ expectations or feedback on supplier quality, and cooperates with other top management personnel in formulating and establishing company policies, operating procedures, innovation plans, and goals for supplier quality
  • 2) Analyzes, evaluates and presents information concerning factors related to suppliers and components such as new regulations, cost of quality, suppliers’ risks, supplier’s performance, and proposals to other members of management team
  • 3) Cooperate with material, purchasing, and GBS team to establish the supplier quality requirements and agreements that is in compliance with regulatory requirements per QSR and ISO 13485
  • 4) Lead SQE team to evaluate, develop, and monitor suppliers and components to ensure they comply with Flex requirements, customer requirements, and regulatory requirements per QSR and ISO 13485, on safety, quality, capability, delivery, environment, society regulation, etc
  • 5) Lead SQE team to measure and track suppliers’ performance and to drive problem solving and continuous improvement
  • 6) Establish and maintain the supplier quality management process and tools, and train SQEs and all peers to ensure compliance with the supplier quality process per QSR and ISO 13485
  • 7) Commit cross-functional support and form good relationships with internal and external customers in order to maintain a strong support system in the organization, to achieve customer satisfaction and to comply with regulatory requirements per QSR and ISO 13485
  • 1) Demonstrates advanced functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills
  • 2) Demonstrates expert knowledge of the function and a thorough understanding of Flex and related business
  • 3) Demonstrates knowledge of multiple functional technologies/processes, industries or functions and understanding of inter-dependencies of such processes at the site
  • 4) Demonstrates expert functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills
  • 5) Demonstrates detailed expertise in very complex functional/technical area or broad breadth of knowledge in multiple areas; understands the strategic impact of the function across sites
  • 6) Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents
  • 7) Ability to effectively present information to top management, public groups and/or boards of directors
  • 8) Ability to effectively evaluate suppliers’ process, management system, capability, and make valid decisions
  • 9) Ability to report and communicate the supplier evaluation and performance result to internal or external customers and peers
  • 10) Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
  • 11) Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
  • 12) Excellent Problem solving skills
  • 13) Ability to define problems, collect data, establish facts and draw valid conclusions
  • 14) Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  • 3) Lean Six Sigma Green Belt or Black Belt certificates are preferred
  • 2) Creates functional processes or technologies
  • 3) Executes functional strategic plans and objectives at the site
  • 4) Has experience in leading major initiatives and provides input to those initiatives
  • 5) May have P&L responsibility for accounts/projects
  • 2) Supports strategic direction for the function
  • 3) Recognizes and develops talent as a key element of executing operational business plans
40

CVG Director Supplier Quality Engineering Systems Resume Examples & Samples

  • Oversight of the CVG Supplier Quality Management QS processes and IT solutions that support effective Purchasing Controls for all purchased materials, components, contract manufacturing, OEM products, and related cGMP services
  • Active participation in the CVG Supplier Quality Council and execution ownership for Medtronic Enterprise Supplier Quality council initiatives
  • Assure that CVG supplier quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement
  • Lead completion of quarterly Quality Management Review reporting for Supplier across CVG BUs (CRHF, CSH, APV)
  • Monitor all CVG Sites for SQE process compliance, consistency, and resourcing levels to ensure Supplier Quality Excellence within Operations Quality
  • Strategy ownership & execution leadership for CVG Supplier Quality Data Management, IT tools and standardization of metrics and processes
  • Program leadership and execution for CVG Programs including Supplier Owned Quality/SQM and Go Green Supplier Risk Reduction. Partner with Sourcing on reduction of Supplier Risk through Go Green Programs and SRMT process
  • Execution of CVG objectives, quality system and compliance improvements, in accordance with the CVG Quality Plan
  • Oversight and leadership for CVG Supplier Quality system integrations for new acquisitions
  • Chair of a CVG CM/OEM CAPA Board, which includes multi-BU CVG Sourcing issues. Assign CAPA Board specialist to ensure effective oversight, metrics, and compliance
  • Oversight, execution, and continuous improvement of centralized supplier control activities, including Approved Supplier List maintenance, supplier audit programs, and supplier scorecard creation and communication
  • Proactively manage quality assurance and compliance activities in order to produce the highest quality products, prevent defects and prevent manufacturing disruptions
  • Create a culture of continuous learning across areas of responsibilities where cultural root cause on quality issues is identified and organizational learning is institutionalized
  • Ensure effective processes are established within the organization to monitor supplier quality and compliance execution
  • Work closely with CVG Business units, Sourcing, Operations and Product Development to meet CVG business needs
  • Create a world class Quality organization ensuring top talent is hired, developed, and retained. Lead a team of program managers, engineers, and analysts to execute CVG programs & initiatives
  • Develop Annual Operation Plan (AOP) and manage spending accordingly
  • Solid line reporting to the CVG Group Senior Director for Supplier Quality, and dotted line to the CRHF Operations Quality VP and CSH/APV Operations Quality VP
  • Minimum of 10 years of experience with increasing responsibility in Sourcing or Supplier Quality functions
  • Minimum of 7 years of experience and knowledge of good manufacturing practices (GMP's) Global, Quality Systems regulations, ISO 13485 and ISO 14971
  • Minimum of 7 years of experience in medical or high reliability product industry
  • Minimum of 5 years of progressive people management experience
  • Experience in a public, government-regulated company
  • Experience setting strategy and objectives for a quality function for a diversified, global business
  • Industry experience with Quality Assurance and/or Quality Management Systems
  • Experience establishing quality policies and practices within a quality function
  • Experience leading and developing a team of employees, including managing subordinate people leaders
  • Masters or other advanced degree
  • 10 or more years of experience in operations and supplier quality
  • 5 or more years of managerial experience
  • Six Sigma Belt certification and/or Lean Sigma certification and experience
  • Highly results oriented and focused on business priorities
  • Strong leadership and influencing skills to drive results in a highly matrixed organization
  • Business and Quality perspective
  • Strong change management and transformation skills
  • Excellent Communication/Presentation Skills
  • Excellent Interpersonal and Talent Management skills
41

Senior Supplier Quality Engineering Specialist Resume Examples & Samples

  • Support new product qualification & implementation projects as the Quality subject matter expert (SME) to ensure all new product projects are robust, well documented, and compliant with all applicable standards and regulations
  • Review of supplier’s Qualification activities for proposed products (e.g. design verification & validation, biocompatibility, release specifications, etc) to ensure product quality that meets BBMI requirements & customer expectations
  • Compile & analyze available data for new suppliers and new products to ensure that new products are capable of meeting BBMI quality standards
  • Create, negotiate, and maintain Quality Agreements. Monitor BBMI and supplier compliance to executed agreements and initiate actions to correct non-compliances when identified
  • Lead Change Control projects as the Quality SME and ensures all stages of changes are controlled, robust, well documented, and compliant with all applicable standards and regulations
  • Facilitate all aspects Corrective and Preventive Action (CAPA) as they relate to PFGs; assist in root cause investigation as needed to ensure appropriate & effective corrective actions and ensure clear, robust, documentation
  • Drive processing of discrepancies, complaints and supplier notification/investigations as they relate to PFGs. Ensure thoroughness and timeliness of investigations and appropriate disposition of products to ensure patient safety and customer satisfaction
  • Lead or support Quality auditing of suppliers to ensure conformance to BBMI requirements
  • Create, maintain & analyze supplier- & product quality-related metrics to identify adverse trends and implement opportunities for improvements
  • Lead continuous improvement initiatives for PFG processes
  • Support internal audits, customer audits and regulatory authority audits
  • Provide timely guidance and decision making on quality related issues as they arise
  • Author and/or revise Standard Operating Procedures to assure efficient, effective and compliant Quality System practices of PFG business
  • Other related responsibilities as directed by Management
  • Knowledge of regulations and standards for US and Canada as they pertain to single-use and active medical devices, pharmaceuticals, and/or software
  • Able to work independently without direct supervision; Self-motivated with exceptional follow-through
  • Able to represent BBMI in a professional manner to suppliers & regulators, as needed
  • Able to perform work duties correctly and accurately within the established procedures and time frames
  • Excellent interpersonal skills, including the ability to work positively and constructively in a cross-functional (Matrix) team environment
  • Excellent verbal and written communication skills; Excellent organizational and presentation skills
  • High level of creativity and flexibility
  • Bachelor's Degree in the discipline of Engineering
  • 10+ years of experience in the medical device (single use and durable devices) and/or pharmaceutical industry
  • A minimum of 2 years within a supplier quality organization
  • Use and understanding of Statistical tools and techniques
  • Intermediate knowledge and use of Microsoft office
  • An advanced Degree in Engineering, Life Science, or related discipline
  • Auditing experience
  • An ASQ certification (CQE, CQM, CRE or CQA)
  • SAP ERP proficiency
  • Will require up to 20% travel, including international
42

Supplier Quality Engineering Resume Examples & Samples

  • Leading a team of Supplier Quality Engineers spanning Electro-Mechanical, Semiconductor and Optics commodities
  • Provide leadership in the assessment of Supplier capabilities, Supplier selection, execution of Supplier Quality Audits and contributions in the definition and implementation of Commodity Strategies
  • Measure and reporting of suppliers’ capability and quality performance
  • Provide leadership in implementing Supplier Quality improvement and defect reduction plans
  • Definition and implementation of Supplier Quality strategic initiatives
  • BS, MS or PhD Degree in Engineering or equivalent
  • 10+ years of experience in Supplier Quality Engineering, Component Engineering, New Product Introduction or Component Manufacturing
  • 5+ years of team leadership and management experience preferably related to supplier quality
  • Represents the 5 Juniper Values: Authenticity, Trust, Deliver Excellence, Pursue Bold Aspirations and Make a Meaningful Difference
  • Crisp verbal and written communication, executive summary capability, and engaging presentation skills
  • Experienced with DMAIC, 8D Approach to Problem Solving and 6-sigma manufacturing techniques
  • Firsthand experience with implementing Key Business or Technical Strategies that had significant business impact
  • Experienced with International Component Suppliers / Manufacturing. Requires flexibility in working hours and schedule
43

Supplier Quality Engineering Manager Resume Examples & Samples

  • Develop and implement business unit supplier quality assurance strategies and processes that aim at ensuring product conformity
  • Establish holistic definition of Cobham’s expectations. Establish mechanisms to communicate these expectations to the supply base, assess supplier understanding and their ability to comply
  • Establish mechanisms that support decision making for sourcing, evaluation and selection of suppliers to be placed on the Approved Supplier List and for selection on a contract by contract basis. Additionally establish mechanisms to identify and mitigate risk with suppliers that are partially capable (i.e. good for some applications, but not for other)
  • Establish mechanisms for joint quality planning with suppliers to minimize total landed cost and maximize the value of the CMS/Supplier relationship
  • Establish standard, risk based methods to validate suppliers conform to requirements. This may include proactive containment during early production or reactive containment due to escape. Conformance methods may occur at CMS, at the supplier and/or at an independent 3rd party
  • Establish and maintain a continuous quality improvement program with suppliers. Improvement should be based upon a holistic rating system that considers impact to the business; primarily Customer Satisfaction and Total Landed Cost
  • Significant Travel may be required for short periods of time. Typical travel will be 25% of the time
  • Flexibility in work day in order to attend required internal/external meetings and teleconferences
  • Strong written, verbal and presentation communication skills and the ability to effectively communicate with people at all levels of the company
  • An advanced degree in Supply Chain Management or Engineering desirable
  • The incumbent must have the ability to manage relationships across multiple cultures
44

Supplier Quality Engineering Resume Examples & Samples

  • 10 years experience in Process / supplier quality engineering activities focus Assembly, Test and substrate
  • Experience with assembly, Test and substrate subcontractor management including addressing and follow up on quality issues and process improvement initiatives
  • Thorough understanding of reliability testing and failure analysis and a good understanding of wafer fabrication is plus
  • Good communication and interpersonal skills. Able to work independently while still being a team player in cross functional teams located in Asia and the US
  • Fluent in Mandarin Chinese and or English
  • LI-APAC
45

Supplier Quality Engineering Coordinator Resume Examples & Samples

  • Perform all duties and promote themselves in a manner that reflects Formet Expectations and Formet’s Visions/Values through Magna’s Employee Charter
  • Follow and abide by all government, Legal, Magna and Formet rules and regulations
  • Contribute to continuous improvement and cost reduction activities
  • Act as the supplier liaison on all aspects of the program during the launch
  • Support the program team from a quality engineering perspective
  • Champion the quality functions of APQP
  • Support the buy off of fixtures and gauges at the Supplier
  • Act as a champion and decision maker for quality related issues
  • Investigate customer and internal concerns to ensure proper action plans being put in place to contain and to prevent recurrence (and across all similar processes) at the Supplier
  • Review Supplier problem reports with resolutions and verify the effectiveness at the Supplier and Formet to ensure that there will not be a recurrence
  • Assist in the training of personnel in all customer requirements when required
  • Track Supplier Performance KPIs
  • Support buy-offs as required
  • Support Supplier development projects/initiatives
  • Review Supplier PPAP packages with Program QEC
  • Support PPAP and PDR on site at supplier
  • Perform and analyze capability / reliability studies as required
  • Attend and / or champion meetings
  • Demonstrate a sense of urgency to achieve results
  • Perform other duties as designated
  • Post-secondary education or equivalent
  • Completion of Quality Assurance Certificate and or Engineering Certificate an asset
  • Must have minimum of two years in the Automotive Quality Field in an Engineering Coordinator position or equivalent
  • Experience in TS 16949 and Advanced GD&T
  • Experience in gauging, fixtures, and metrology
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Supplier Quality Engineering Manager Resume Examples & Samples

  • Masters degree in mechanical, electrical or biomedical engineering or related field and a minimum 5 years of related experience
  • Progressive leadership experience in functional area or related field
  • Skillful in formulating strategies, tactics and action plans to achieve results
  • Strong focus on developing an organizational culture that fosters teamwork
47

Supplier Quality Engineering Manager Resume Examples & Samples

  • Must have 5-8 years of Supplier Quality Management Experience
  • Must have either an Internal or External Auditor Certificate for ISO 9001
  • Experience with building and construction materials specific to Bathroom Fittings or Kitchen or Electronics experience
  • Ability to listen and understand customer expectations and deliver on quality metrics is key to this role
  • Strong Analytical Ability to drive cost management is important
  • Lean Six Sigma Green or Black Belt certificates
  • Bilingual abilities specifically in Spanish are a plus