Senior Quality Engineer
Senior Quality Engineer
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Job Description
What you will do-
In this role you will partner with the Global Supplier Network and Finish Goods Operations (FGO) to ensure our external supply chain consistently meets Strykers high standards for quality service and cost. Acting as a liaison between Stryker and its OEM (Original Equipment Manufacturer) and CM (Contract Manufacturer) suppliers you will support supplier quality systems drive continuous improvement initiatives and collaborate with cross-functional teams to guarantee compliance with regulatory requirements and company standards.
Key Responsibilities:
- Serve as the main liaison between Stryker and OEM/CM suppliers driving effective continuous improvement initiatives.
- Provide technical support for supplier quality system assessments and performance evaluations.
- Ensure clear ownership reporting and communication of all supplier-related material quality issues within assigned commodities.
- Oversee OEM/CM material-related processes including Material Review Board (MRB) activities ensuring timely resolution of non-conforming products.
- Act as the point of contact for OEM/CM quality during external (e.g. FDA Notified Bodies) and internal audits.
- Track and report OEM/CM performance metrics (KPIs) enabling regular reviews and contributing to Monthly Business Reviews.
- Manage and maintain the Approved Supplier List (ASL) in collaboration with the Procurement team.
- Drive continuous improvement activities in supplier quality in close partnership with Finish Goods Operations Manufacturing Quality and Business Units.
What you need-
Required:
- Bachelors degree in Engineering Quality or related technical field.
- Experience with supplier quality management or supply chain in a regulated industry.
- Knowledge of regulatory standards (e.g. FDA ISO 13485 GMP).
Desired:
- Experience working directly with OEM/CM suppliers in the medical device or similar regulated sector.
- ASQ Certification (e.g. CQE CQA CSSGB) or equivalent.
- Experience with auditing suppliers and managing Approved Supplier Lists.
- Lean/Six Sigma or continuous improvement project experience.
Required Experience:
Senior IC
Employment Type
Full-Time
