Staff Supplier Quality Engineer Job Description
Staff supplier quality engineer
provides training on Quality tools, Six Sigma, Sampling, Statistics, Root Cause Analysis, FMEA, Control plans, Design of Experiments.
Staff Supplier Quality Engineer Duties & Responsibilities
To write an effective staff supplier quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included staff supplier quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
System Requirements (21 CFR 820) and ISO regulations (ISO 13485) to ensure products and services are provided to customer requirements
Develop, manage, and maintain Supplier Quality Management metrics to enable proactive metric driven management of the Quality Supplier relationships and purchasing controls processes commensurate with the risk to product safety and efficacy
Utilize analytical and problem solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team
Develop and utilize Leading Indicators to ensure timely identification of risk/business challenges and opportunities
Analyze quality data and identifies trends impacting risk benefits requirements of product and quality systems for external suppliers
Collaborate with operations and franchise operations development on process/product improvement projects
Provide recommendations or proposed changes to components based on data analysis using Process Excellence tools
Understand the key consumers and suppliers of the business, the products and how one's own performance can ultimately impact the customer
Effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management lifecycle
Serve as lead auditor for supplier audits based on yearly audit schedule
Staff Supplier Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Staff Supplier Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, PE, CQM, ISO, RABQSA, SQA, CAPA, CMQ/OE, FMEA
Education for Staff Supplier Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the staff supplier quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Education, Life Science, Medical, Mechanical Engineering, Manufacturing, Chemistry, Biological Science
Skills for Staff Supplier Quality Engineer
Desired skills for staff supplier quality engineer include:
FMEA
Statistics
MSA
ISO
Lean manufacturing
Risk Assessment and Process Validation
Sampling Planning
Sampling plans and statistics
Techniques like six sigma
CGMP regulations
Desired experience for staff supplier quality engineer includes:
Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager
Assist in the maintenance of the supplier quality relationship (follow-up of corrective actions, coding for metrics)
Understand or anticipate the customer’s needs and adds value by providing specific metric information tailored to the particular business environment
Take actions to identify internal customer requirements and translates customer requirements into potential proactive improvements to components or supplier quality systems
Respond proactively to changing regulatory and business needs
Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
Staff Supplier Quality Engineer Examples
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Staff Supplier Quality Engineer Job Description
Job Description Example
Our growing company is looking for a staff supplier quality engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for staff supplier quality engineer
- Support and provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations audits
- Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements
- Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, Sampling Plans Development and Review, and Supplier Management and Certification
- Develop, write and approve as required policies, procedures, test methods and specifications
- Serve as Subject Matter Expert (SME) for Purchasing Controls procedures and champions the management of changes to Medical Device (MD) Standards within Ethicon+CSS
- Utilize technical expertise specific to applicable categories (ex
- Monitor, trend, identify issues, and drive the resolution of supplier quality issues execute and lead negotiations of External Manufacturer Quality Agreements
- Act as the process quality subject matter expert on cross-functional project teams, development and analysis of monthly and quarterly metrics
- Provide strategic direction and systems of execution for Quality-related elements of supplier management activities, inclusive of
- Support and develop site, regional & global Quality Management System elements related to supplier management to meet requirements across all key business sectors, Defense/Security/Aerospace, Healthcare/Life Sciences
Qualifications for staff supplier quality engineer
- Experience with process validations and the use/application of statistical tools is preferred
- Knowledge of Non-Conformance Reports (NCRs) and Corrective and Preventive Action (CAPA) is preferred
- Prior experience in sampling, design of experiments, process capability analysis the capability to review manufacturing processes like control plans, process control and quality control is highly desired
- At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science
- Green Belt or Black Belt certification is preferred
- Strong understanding of Medical Device and/or Pharmaceutical Regulations is required
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Staff Supplier Quality Engineer Job Description
Job Description Example
Our growing company is hiring for a staff supplier quality engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for staff supplier quality engineer
- Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements
- Root cause analysis of processes related manufacturing defects and warranty concerns
- Identify and communicate supplier initiated changes and ensure the suppliers follow change control requirements
- Serve as a subject matter expert for supplier evaluations, share expertise within Campus, Divisional, and Site
- Support strategic sourcing projects through proactive supplier evaluations, due diligence, and/or exploratory audits
- Complete on-site audits of suppliers’ Quality Management Systems through risk based processes audits
- Report non-conformance and performance data to highlight systemic supplier issues
- Support the creation and execution of supplier development plans by identifying potential process improvements
- Drive continuous improvement actions within supplier processes to reduce part related defects (DMP)
- Evaluate and qualify new suppliers and advanced technology processes to support product innovation
Qualifications for staff supplier quality engineer
- Good knowledge of lean tools and concepts
- The ability to perform "hands on" troubleshooting and problem solving is preferred
- Be highly collaborative, with expected internal and external interfaces
- Bachelor's degree in Engineering four-year college or university is preferred
- Lead Component Qualification process for Supplier Changes
- This position may require travel and will be based in a supplier location and/or Ethicon Facility
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Staff Supplier Quality Engineer Job Description
Job Description Example
Our growing company is hiring for a staff supplier quality engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for staff supplier quality engineer
- Review test protocols and reports to ensure design outputs will or have met input requirements, acceptance criteria was appropriately defined and has been met and any deviations have appropriate rationale and are documented correctly
- Apply appropriate Quality Engineering and PEx tools
- Ensures quality is maintained following standard practices and procedures, participates in identifying new technologies and processes, may lead small project group
- Adheres to and may help develop an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
- Evaluates and manages supplier part process changes (revision, die shrink, fab location, ) and end of life notification
- Lead timely and compliant Internal and Operations audits as required and directed by the internal audit program
- Identify and plan training to address gaps in both skills and behavior
- Actively participate on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
- Plan, execute, report and follow-up on supplier quality system audits - must be able to travel domestically and internationally up to 50% of the time
- Support internal and supplier root cause investigations and corrective actions
Qualifications for staff supplier quality engineer
- A minimum of a Bachelor's degree in a technical discipline (Math, Science, Engineering or Information Technology) is required
- A minimum of 3-5 years work experience is required
- Minimum of five years of semiconductor industry experience with a minimum of 2 years working directly with foundries such as TSMC, SMIC, UMC, GF, Grace
- Thorough understanding of device physics, reliability concepts and wafer processing
- Hands-on experiences of Fab inline and PCM process control
- Excellent verbal, written and presentation skills (in both Mandarin and English)
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Staff Supplier Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is looking for a staff supplier quality engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for staff supplier quality engineer
- May be designated by management as the Chairperson on the Supplier Review Committee (SRC)
- May serve as the supplier quality representative during internal audits and for designated suppliers
- Works as a member of the design team, as required
- Certified (i.e., Possesses an ASQ CQA Certificate) or otherwise professionally trained to perform quality system audits with a minimum of 4 years of hands-on experience in conducting and leading quality systems audits and supplier qualifications in the medical device industry
- Work directly with suppliers to ensure that the product or service received meets requirements and specifications
- 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 different projects like Kaizen, PE (GB/BB) and lean
- Responsible for the generation or updates to Supplier Quality Agreements
- Responsible to review, create and approve changes to procedures, work instructions, forms, specifications, inspection reports and other related controlled documentation
- Visit and evaluate suppliers thru audits or technical assessments
Qualifications for staff supplier quality engineer
- Experience with injection molding preferred
- A Bachelor's degree in engineering and minimum of six years’ experience in the medical device or pharmaceutical industry required
- Ability to develop statistically appropriate inspection plans at suppliers that incorporate critical to quality features and severity
- Bachelor's degree in Engineering - Electrical/Electronics, Industrial, Mechanical Engineering
- Minimum 8 years of relevant experience which may include WLCSP Bumping, back-end assembly engineering and supplier quality management
- Strong Experience in semiconductor packaging assembly & test (WLCSP Bumping, QFNs, MCMs, BGAs, LGA packaging)
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Staff Supplier Quality Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a staff supplier quality engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for staff supplier quality engineer
- Lead activities associated with supplier risk management
- Lead activities associated with supplier process improvement
- Perform and Support supplier/ EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier
- Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned
- Support other JJV sites in the areas of this job description, as assigned
- Serve on and support the global Supplier Quality network towards the effective promotion and alignment of organizational goals to the company’s mission and vision
- Work with the Associate Director of Supplier Quality to lead and facilitate the Supplier Management Action Team (SMAT) ensuring timely and effective collection and reporting of data
- Develop and share subject matter expert knowledge of global regulations
- Support the administration and coordination of the global supplier audit program and annual supplier audit plan, including suppliers incorporated though acquisition activity
- Develop standard operating procedures, specifications, and provides technical transfer and validation support
Qualifications for staff supplier quality engineer
- Expert level knowledge of assembly or Bumping processes development such as Sputtering, Photo Resist Coating/Development/Exposure, PBO/PI coating, Cu/Solder Plating, Wet/Dry Etching, Die Attach, wirebonding, flip chip, SMT, Molding, Shielding, wafer backgrinding, dicing, Tape lamination, Laser Marking, RF/Analog Product Electrical Test, Tape/Reel, Automatic Vision Inspection, Wafer Probe etc
- Experience in problem solving techniques such as 8D
- Understanding of DMAIC technique, green belt or black belt certification a plus
- Ability to travel & must be proficient in English
- Must be a strong driver, demanding perfect quality from suppliers
- Must be a strong team player, detail oriented, proactive, self-driven, and results-oriented