Supplier Quality Engineer II, Medical Device
Overview
You will own supplier quality for Shockwave Medical, ensuring seamless operations across procurement, R&D, and manufacturing. Partner with cross-functional teams and external suppliers to resolve quality issues, drive corrective actions, and elevate supplier performance. Monitor metrics, lead audits, and manage CAPA and SCAR processes. This role stands out with direct impact on product launches and compliance under ISO 13485 and FDA regulations.
What You'll Do10
- 1Partner with Procurement, R&D, and Operations to resolve supplier quality issues within 30 days.
- 2Monitor supplier performance metrics and report risks to management using Minitab dashboards.
- 3Lead supplier audits and coordinate corrective actions with SCAR and CAPA processes.
- 4Drive root cause analysis with suppliers using Fishbone and Control Charts.
- 5Qualify new components and manage change projects with SolidWorks and GD&T.
- 6Compile Supplier Scorecards and present trends to leadership.
- 7Investigate NCRs and drive to closure with cross-functional teams.
- 8Review and approve Document Change Orders (DCOs) for quality documentation.
- 9Support Manufacturing Engineering in process improvements and MRB meetings.
- 10Train Contract Manufacturers on inspection and testing procedures.
Requirements9
- 13+ years in supplier quality engineering within medical devices.
- 2Bachelor's degree in engineering or related field.
- 3Experience with cGMP, FDA 820 QSR, and ISO 13485.
- 4Proficiency in Minitab for DOE, MSA, and capability analysis.
- 5Six Sigma and Lean Manufacturing knowledge with Lean Six Sigma Green Belt certification.
- 6Hands-on with Process Validation (IQ/OQ/PQ) and Risk Management (dFMEA, pFMEA).
- 7Skilled in Root Cause Analysis tools and CAPA for non-conforming materials.
- 8Strong GD&T and SolidWorks skills for engineering drawings.
- 9Good Documentation Practices (GDP) and metrology tools (Calipers, MicroVu, Go/No-Go Gages).
Salary Insight
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