Staff Supplier Quality Engineer Resume Sample
Lenna Streich
769 Darrel Manors,
Chicago,
IL
+1 (555) 654 6542
Work Experience
Senior Staff Supplier Quality Engineer
09/2016
-
PRESENT
Houston, TX
- 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
- Participate as a team member with other Edwards’ associates and facilities to assure a consistent application of the assigned Quality System element(s)
- Experience in quality assurance field with emphasis on medical devices or life sciences
- Strong experience with failure investigations and failure report writing, inspection, calibration, trend analysis, and supplier/internal auditing
- Read drawings, schematics, etc
- Perform component testing as required
- Working knowledge of AVL, MRP, ISO, FDA, GMP
Staff Supplier Quality Engineer
12/2012
-
03/2016
New York, NY
- Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work
- Ensures validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and Industry best practices
- Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services
- Expert knowledge of CAPA elements is required
- Assesses non-conformances and leads closure of SCARs as needed
- Develop supply base to achieve supplier score card performance and meet future product needs
- Lead problem solving initiatives on supplier component concerns
Senior Staff Supplier Quality Engineer
02/2008
-
11/2012
Phoenix, AZ
- Leads component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
- Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics
- Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities
- Works cross-functionally to track and trend supplier improvements
- Assists with quality agreements of assigned suppliers
- Assists with quality aspects of business reviews
- Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as needed
- Reads, writes, and understands specifications and inspection criteria
Education
Washington State University Vancouver
2002 - 2007
Engineer's Degree in Engineering
Professional Skills
- Strong statistical, root cause analysis, communication and problem-solving skills are required
- Excellent communication, partnership, and analytical skills are required
- Experienced with validation, certification and auditing of suppliers
- Strong knowledge of verification and validation, per FDA-QSR
- Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle, Agile and MiniTab)
- Experience in a quality role or Manufacturing Engineering supporting high volume manufacturing
- Experience in a quality role or Manufacturing Engineering supporting high volume manufacturing
How to write Staff Supplier Quality Engineer Resume
Staff Supplier Quality Engineer role is responsible for manufacturing, documentation, engineering, design, database, root, leadership, reporting, training, procurement.
To write great resume for staff supplier quality engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Staff Supplier Quality Engineer Resume
The section contact information is important in your staff supplier quality engineer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Staff Supplier Quality Engineer Resume
The section work experience is an essential part of your staff supplier quality engineer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous staff supplier quality engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular staff supplier quality engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Staff Supplier Quality Engineer resume experience can include:
- Auditing, root cause analysis, quality engineering skills in design validation, process validation, and effects analyses
- Works with Sourcing, Purchasing, R&D, LCM, Quality Assurance and Engineering ensuring that Purchasing Controls are effectively implemented
- Communicates effectively and collaborates well in a team environment with minimal supervision
- Works and communicates effectively and professionally in a team environment with minimal supervision
- Strong understanding of Manufacturing processes like Injection Molding, Extrusion, Machine Shops, etc
- Possesses a good understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
Education on a Staff Supplier Quality Engineer Resume
Make sure to make education a priority on your staff supplier quality engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your staff supplier quality engineer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Staff Supplier Quality Engineer Resume
When listing skills on your staff supplier quality engineer resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical staff supplier quality engineer skills:
- Effectively articulate verbally and in writing, results and conclusions to technical and non-technical personnel
- Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
- Conduct benchmarking with internal sites to develop more effective methods for improving quality
- BS in engineering, or engineering related discipline, or equivalent work experience required
- Experience in supplier quality or quality engineering
- Provide support to PM in educating the core team on good design control and documentation practices
List of Typical Experience For a Staff Supplier Quality Engineer Resume
1
Experience For Senior Staff Supplier Quality Engineer Resume
- Solid experience with IS0 13485 or IS0 90001 and/or 21 CFR Part 820
- Experience in Supplier Quality
- Helps define and validate quality assurance and quality control processes
- Ensures validation methods of critical 1st and 2nd tier suppliers are aligned with international standards, global regulations, and Industry best practices
- Strong knowledge of CAPA elements is required
- Professional experience of 5 years in a related industry is required
2
Experience For WW Staff Supplier Quality Engineer Resume
- Support supplier quality management in executing tactical activities sustaining corporate initiatives and/or departmental objectives
- Knowledge and understanding of FDA and international regulatory standards for medical devices is required
- Mentor and Support entry level Quality Engineers as a subject matter expert with respect to quality engineering principles and techniques
- Communicate supplier quality risks to upper management, and suggesting improvements and cost savings where possible
- Reads schematics and mechanical drawings
- Performs supplier qualification audits, monitors supplier performance, provides supplier program metrics and periodic reports, and administers the supplier corrective action system, as needed
3
Experience For Staff Supplier Quality Engineer Resume
- Possess an in-depth knowledge of the Quality Systems Regulations and international quality systems and medical device standards. (Reference Examples: US Title 21 Part 820; ISO 13485; ISO 14971, etc.)
- Partner externally and internally (JJDCC/MD/Enterprise) to provide quality assessment and supplier quality support
- Support cross-functional teams in critical, complex projects of major impact on business unit sales and profitability
- Partner internally and externally to compile and evaluate test data to perform root cause analysis of raw material failures
- Direct and participate in special projects as requested by Management
- Provide timely business support for the assigned Ethicon Supplier Quality Management (SQM) function globally
- Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems
- Partner with Procurement/Source, R&D, Engineering, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions
4
Experience For Senior Staff Supplier Quality Engineer Resume
- Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes
- Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and closure communication including ASL updates and material/supplier qualifications
- Lead and provide SQM support for appropriate site Quality and Compliance audits related to supplier/purchasing controls
- Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision
- Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects
- Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
- Identify business opportunities for and lead the preparation/management of Supplier Quality Agreements (SQA)
- Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
- Ensure alignment of SQM Quality Systems with current regulatory requirements, industry trends, J&J standards, policies, procedures, and work instructions
5
Experience For WW Staff Supplier Quality Engineer Resume
- 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
- Drives continuous improvement with procedures, policies and quality assurance methodologies including but not exclusive to: new material qualification, end of life materials/components, product development process, supplier requests for material changes and sustaining engineering
- Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports
- Performs value-engineering to improve existing components and products in cost, technology, quality, health and safety
- Reviews data for and resolve issues concerning incoming, in-process, and final inspection and test activities
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur
- Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures
6
Experience For Staff Supplier Quality Engineer Resume
- Responsible for defining supplier qualification requirements for OEM and custom materials and devices
- Participates in new supplier qualification and audit processes
- Point of contact for technical communication with suppliers
- Qualifies new components and ensures Purchase Part Specification release
- Evaluates and manages supplier part process changes (revision, die shrink, fab location, etc.) and end of life notification
7
Experience For Senior Staff Supplier Quality Engineer Resume
- Evaluates alternate sources of supply for improved cost, reduced lead time or risk
- Maintains Approved Vendor List (AVL) to ensure materials meet design requirements
- Helps define quality rules, tools and controls for inspection
- Works with suppliers to ensure quality system requirements are understood and successfully met
- Supports completion of Design File requirements applicable to supplied components, devices, and services
- Facilitates risk management activities with suppliers
- Functions as a lead auditor for supplier audit program
- Assesses nonconformances and leads closure of supplier actions as needed
8
Experience For WW Staff Supplier Quality Engineer Resume
- This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills is required
- Advanced understanding of V&V, statistical techniques, and risk management
- Design and maintain the supplier quality management system according to written policies and procedures
- Provide quality guidance to other departments
- Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and administer the supplier corrective action system
- Frequently travel in the U.S. and internationally
- Works with team to establish and maintain the Supplier Audit Schedule and ensures compliance with this schedule
9
Experience For Staff Supplier Quality Engineer Resume
- Ensures Quality Agreements are established, where needed, and that any joint periodic business reviews are conducted
- Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement
- Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics; utilizing these techniques as appropriate per Dexcom and/or industry recognized standards
- Takes the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs
- Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
10
Experience For Senior Staff Supplier Quality Engineer Resume
- Possess an in-depth and professional level of knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485
- Work directly with suppliers to ensure that the product or service received meets requirements and specifications. Responsible for generating quality standards and maintaining current standards. Develop and implement improvement programs for suppliers. Attend and participate in quality metric reviews
- Responsible for generating corrective and preventive actions to suppliers, and verification of the effectiveness of such actions for approval and closure. Responsible for follow ups, implementation and closure of corrective and preventive actions either internal or external. Collect and distribute supplier performance data
- Support suppliers on the implementation of improvement plans (example SPC, Gage R&R, etc) Support and lead initiatives to improve supplier’s performance in order to certify them or reduce receiving inspection activities. Participate in the analysis of complaints related to suppliers
- Responsible to review, create and approve changes to procedures, work instructions, forms, specifications, inspection reports and other related controlled documentation. Support receiving inspection group to take actions when a nonconformance is received
- Visit and evaluate suppliers thru audits or technical assessments. Responsible for communicating business related issues or opportunities to next management level
- Understands corrective and preventive action systems (CAPA), statistical analysis techniques, GMP, QSR, ISO 13485 requirements, validation, certification and auditing of suppliers is required
- Identify and define correction actions and follow-up to assure completion and effectiveness
List of Typical Skills For a Staff Supplier Quality Engineer Resume
1
Skills For Senior Staff Supplier Quality Engineer Resume
- Effective communication at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc
- Provide project with direction on sound design control strategy compliant with QSR and QMS, supporting a product release that is safe and effective, sustainable in the field, and able to withstand external audit
- Demonstrated experience in the qualification of suppliers of components, assemblies, and services in the medical device industry
- Manage shifting priorities with minimal difficulties
- To ensure good yield of incoming products, analyze any out of control and low yield and make proper action and timely
- Responsible for the supplier process maintenance such as monitoring the supplier process procedure and maintain good relationship with the suppliers
- Strong understanding of measurement systems - qualification of the system and interpretation their results
- Thorough understanding of Process Validation (IQ,OQ, PQ, PPQ)
- Strong knowledge of quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts
2
Skills For WW Staff Supplier Quality Engineer Resume
- Experience in Quality Assurance working with suppliers is required
- Basic knowledge of project management tools. Experience implementing tools in desired
- Strong understanding of GMP, QSR, ISO 13485 requirements
- Help scope a QSR compliant and effective risk management plan
- Possess and exercise excellent business acumen
- Ensure all Jiras are answered in timely manner and verify CA effectiveness
- Experience in ISO 13485 based quality systems
- Ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed
3
Skills For Staff Supplier Quality Engineer Resume
- Automotive / Aerospace experience acceptable
- Strong initiative and the ability to conduct hands-on work
- Achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)
- Strong knowledge on corrective and preventive action systems (CAPA)
- Lead or support troubleshooting activities, validations, and raw material/process improvements
4
Skills For Senior Staff Supplier Quality Engineer Resume
- Experience with supplier quality systems development is highly desired
- Understand Forging, Die-casting and machining process, able to analyze process and cutting path
- Understand Geometric Dimensioning & Tolerancing, able to analyze drawing, process step and correct measurement
- Proficient at speaking, writing and understanding English
- Decide quality direction and support of new, existing or modified manufacturing processes, including production scale-up
5
Skills For WW Staff Supplier Quality Engineer Resume
- Manage work with a positive attitude while working in a fast-paced manufacturing environment
- Provide support on non-conformance materials activities including MRB review/ out plant rework, and scrapping process
- Assist in developing and reporting appropriate performance and quality metrics
- Lead, develop, and implement supplier/purchasing controls and associated activities including ASL management
- Review test plans for appropriate size/scope to meet product intended use, claims, customer and marketing requirements, functional and regulatory requirements
- Help scope and attend technical assessments and design reviews by providing quality system regulation guidance
- Work in an office environment, audit manufacturing sites with travel to supplier sites approximately 25 percent of the time
- Generate test protocols, monitor testing,issue qualification test reports and approve components for use in products
6
Skills For Staff Supplier Quality Engineer Resume
- Perform supplier performance review. Responsible for the assurance of incoming quality level to meet and achieve corporate or customer standards
- Proficient in problem solving techniques such as 5 why, deep dive, & others
- Thorough understanding of Root Cause Analysis principles
- Thorough understanding of FMEA process and development
- Thorough understanding of GR&R and process capability
- Provide input to DesignEngineering on new component technology and assist in component selection with quality and reliability analysis
- Participate in decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives
7
Skills For Senior Staff Supplier Quality Engineer Resume
- Possess the ability to multi-task, while maintaining high attention to detail
- Work with suppliers to ensure process is proper set-up for manufacturing
- Process monitoring for its healthy and predict what could goes wrong.6. Initiate new tools for process control/healthy index
- Understand statistical process control, sampling plan, data analysis, able to design process control plan
- Eager to know, keep continue learning for new process technology
- Advanced understanding of V&V, statistical techniques, test method development, and risk management
8
Skills For WW Staff Supplier Quality Engineer Resume
- Basic knowledge on statistical analysis and problem-solving techniques
- ASQ (or other) certified in Quality Engineering and/or Quality Auditor is desired
- Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for SQM
- Supervise 2 to 3 supplier quality engineers
- Attend and guide product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
9
Skills For Staff Supplier Quality Engineer Resume
- Help perform periodic DHF audits, identify design control gaps and help team come up with solutions
- Investigates field failures related to supplier materials. Develop
- Generates and maintains incominginspection procedures. Trains inspectors to these procedures
- Develops and/or sources inspection tools and equipment
- Able to work extra time based on requirements
- Perform tasks with greater scope and minimal oversight from the manager
10
Skills For Senior Staff Supplier Quality Engineer Resume
- Communicate and collaborate extremely well
- Prior experience in sampling, design of experiments, process capability analysis as well as the capability to review manufacturing processes like control plans, process control and quality control is highly desired
- Join force with procurement engineering team to develop the appropriate business strategies with supplier in support of company's overall business objectives
- Lead commodity Supplier Quality Engineer and guide team on process controls & conformance
- Feedback & coordinate with DE team for corrective actions due to design related issue
- Anticipate production problems concerning incoming material quality and work hand in hand with procurement engineering/ operation/ test/ ME and development team to drive for supplier continual improvement
- Responsible for monthly CSI report (Customer Satisfaction Index)
- Proficient in Microsoft Office tools (Word, Excel, Powerpoint, Visio & Outlook)
- Lean Six Sigma certification - Black Belt or Green Belt
List of Typical Responsibilities For a Staff Supplier Quality Engineer Resume
1
Responsibilities For Senior Staff Supplier Quality Engineer Resume
- Assess the Applied Technology approach to supplier quality management and revise existing/develop new systems and techniques to improve effectiveness
- Possess supplier management and development experience in a manufacturing environment
- Foster strong relationships with Stryker’s supplier-partners
- Experience in the Medical Device industry and/or Pharmaceutical industry is required
- Drafting, establishing and providing relevant information detailed in quality and change agreements
- Executing and documenting supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs)
2
Responsibilities For WW Staff Supplier Quality Engineer Resume
- Leading and supporting supplier assessments and audits for compliance to regulations, agreements, standards and documented processes
- Acting as the primary contact of supplier quality department at its location
- Provide support to development, engineering and manufacturing functions for transfer s and sustaining activities
- We foresee up to 25% travel, including possible international travel
- Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products
3
Responsibilities For Staff Supplier Quality Engineer Resume
- Understands basic project management tools is required
- Understands specification drawings and departmental procedures. Understands Six Sigma tools, preferably Green Belt certified or higher, is required
- Develop and implement quality standards, understands business principles is required
- Evaluate supplier quality systems and strategies compliant with regulatory and quality system requirements
- Support process and system improvement projects as assigned by manager
- Prepare, conduct, monitor and report on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards
- Partner with Procurement/Sourcing, R&D, Engineering, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions
- Identify business opportunities for and lead the preparation/management of Supplier Quality Agreements (SQA)Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
- Establish, maintain and improve quality systems which demonstrate robust and comprehensive supplier quality records
4
Responsibilities For Senior Staff Supplier Quality Engineer Resume
- Adding, removing and updating quality system supplier information while ensuring accurate supplier information on the Approved Supplier List
- The selection, categorization and qualification of suppliers and associated processes
- Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects
- Lead and manage complex supplier quality efforts to include New Supplier / Product Introductions and manage cross-functional teams to accomplish project deliverables
- Support and/or lead program/plant/facility/franchise/enterprise based initiatives and projects as required
- Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier and Edwards receiving inspection Test method validation
- Manage supplier Notification of changes
- Lead supplier management initiatives
- Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics; utilizing these techniques as appropriate per our client's and/or industry recognized standards
5
Responsibilities For WW Staff Supplier Quality Engineer Resume
- Strategically lead supplier performance improvement projects in an effort to increase the supplier capability of consistently meeting Illumina’s requirements
- Physical/Mental Demands & Work Environment: Ability to lift up to 50 lbs. occasionally
- Little or no exposure to hazards
- Lead and provide SQM support for appropriate site Quality and Compliance audits related to supplier/purchasing controls; lead and support Purchasing Control Audit Readiness
- Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions
- Provide subject matter expertise to manufacturing sites in Asia and Tool business to manage supplier performance and to develop new suppliers and new part qualification
- Act as a focal point between Coherent and supplier for technical communication to identify solutions to complex problems with a focus on continual improvement practices to drive Corrective Action and Preventive Action
- Facilitate supplier process development such as Precision Cleaning technologies (VOC control), Process Characterization, Statistical Process Controls, etc
- Perform first level analysis on material related issues. Engage with external laboratories or institutions for failure analysis support
6
Responsibilities For Staff Supplier Quality Engineer Resume
- Conduct supplier site audit to assure compliance to documented requirements
- Participate in Material Review Board meetings to support supplier issue determination. Initiate SCARs and follow up on effective NCR and SCAR closure with suppliers
- Possess technical expertise pertaining to Manufacturing processes/commodities such as metal machining, die cast, PCBA and optical components
- Knowledge of Cleanroom protocol, parts cleaning technologies, surface plating/coating techniques and contamination control methodologies
- Communicates internally within departments like engineering, production, quality and supply chain so as to find out measures on how to improve overall
7
Responsibilities For Senior Staff Supplier Quality Engineer Resume
- Develop and maintain Key supplier scorecard performance metrics
- Support First Article Inspection & Qualification efforts for second source or localization programs
- Excellent interpersonal skills with good verbal and written communication skills. Capable of interacting effectively with Suppliers' Management level and internal to Coherent
- Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities
- Provide ongoing Supplier Quality engineering support throughout the product life cycle
- Ensure an un-interrupted supply of conforming components to Stryker Operations
- Root cause analysis of part related manufacturing defects and warranty concerns
8
Responsibilities For WW Staff Supplier Quality Engineer Resume
- Update prints and generate Engineering Change requests
- Support manufacturing transfer projects
- Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations
- Manage supplier initiated changes; serve as the “change owner” in Stryker’s change management system
- Update gage plans and attribute charts
- Create and execute supplier development plans
9
Responsibilities For Staff Supplier Quality Engineer Resume
- Evaluate and qualify of new suppliers, especially those with advanced technologies, to support product innovation
- Make pro-active supplier site visits
- Leads supplier audits to drive supplier qualification, compliance, and continuous improvement
- Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis
- Participates in company internal and external audits
- Hosts or supports business meetings with suppliers and other functions
- Participates in Data Review Boards and Management Reviews
- Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO)
- Report on contract manufacturer performance metrics
10
Responsibilities For Senior Staff Supplier Quality Engineer Resume
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required
- Six Sigma, Lean, or ASQ Certification and trainings
- Implement SQ strategy and follow Supplier Quality standards
- Oversee supplier change requests (SCR) with Procurement
- Manage PVE's – Process verifications (First Article Inspection, Control Plans, Critical to Quality, Gage R&R, Capability studies, FMEA)
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