Supplier Quality Engineer

Job Description:
(Tasks/Responsibilities)

Conduct Supplier Audits per ISO 13485, FDA CFR part 820 -Monitor Supplier performance to drive improvement initiatives and ensure medical device quality -Participate in New Project teams -Provide manufacturing and process control guidance for successful new product launches -Lead and mentor suppliers on continuous improvement projects and quality system implementation projects -Mentor colleagues and suppliers' engineers in enhancing knowledge of quality systems regulations for medical devices including ISO 13485 and FDA part 820. -Ensure that quality systems and processes conform to established standards (including ISO 13485) and agency guidelines (including FDA part 820) -Lead supplier quality initiatives to implement manufacturing best practices using Lean and Six Sigma.

Skill Requirements:

* Experience in development of technical user documentation required. * Minimum of 6 years of related experience required with several years in a SQE role. * Lean Manufacturing and Six Sigma skills. * Statistical Analysis experience and knowledge. * Quality System Implementation experience. * Supplier Metric System development and implementation experience. * Medical Device Manufacturing experience. * ISO 13485 and FDA CFR part 820 regulations experience and knowledge. * FDA , ISO and Internal Audit experience. * Supplier Auditing Experience.

Education Requirements:

BS in Engineering or other related discipline required.
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