Senior Quality Engineer
$77.7k - $129.5kStryker Orthopaedics
Senior Quality Engineer position at Stryker in Kalamazoo, Michigan, supporting medical device instruments. The role involves developing quality methods, investigating nonconformances, analyzing performance data, and collaborating with manufacturing and engineering teams to ensure products meet regulatory standards throughout their lifecycle.
Responsibilities
- Develop and implement quality methods for process control, inspection, testing, and defect prevention
- Investigate nonconformances, conduct root cause analysis, and manage corrective and preventive actions
- Review and disposition nonconforming product through material review processes
- Analyze quality data and trends to identify and address product or process risks
- Support supplier quality improvement, manufacturing transfers, audits, and engineering change evaluations
Requirements
- Bachelor's degree in Engineering, Science, or related technical field
- Minimum 2 years quality engineering experience in regulated industry
- Medical device regulatory requirements knowledge (U.S. and international)
- Nonconformance investigation and corrective action management experience
- Supplier quality or manufacturing process improvement experience
- Risk management and statistical process control expertise
Compensation: $77,700 - $129,500 USD Annual
Vacancy posted 19 days ago
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