Supplier Quality Engineer

New Yesterday

Technical/Functional Skills : • Medical Device Domain Experience • Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820 • Knowledge of Gage R&R, QFD, MSA, , Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes • Knowledge of Validation and verification activities (IQ/OQ/PQ)
Roles & Responsibilities: • Ensures that suppliers deliver quality parts, materials, and services • Qualifies suppliers according to company standards (PPAP- Production Part Approval Process) and may administer a Certified Supplier Program in receiving inspection • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation • Works with supplier to obtain each deliverable according to the PPAP procedure and evaluate adequacy to the requirements • Must have experience with PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results • May act as a mentor to colleagues or may direct the work of other lower level professionals • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. • May act as a mentor to colleagues or may direct the work of other lower level professionals. • The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.
Experience Required: • Bachelor's Degree in engineering or Technical Field or equivalent combination of education and work experience • Min 3 years of related experience • Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. • Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820. • Good communication and interpersonal skills. • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. • Advanced computer skills, including statistical/data analysis and report writing skills. • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). • ASQ CQE or other certifications preferred. • Experience working in a broader enterprise/cross-division business unit model preferred.
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Location:
Woburn, MA, United States
Category:
Architecture And Engineering Occupations

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