Engineering Manager, Post Market Quality
$118k - $196.7kStryker Sustainability
Stryker seeks an Engineering Manager for Post Market Quality to lead global product quality, failure analysis, and regulatory reporting within the Endoscopy division. The role oversees complaint handling, post-market surveillance, and manages a team of quality professionals in Tempe, Arizona.
Responsibilities
- Lead and direct post-market quality team, fostering accountability and continuous improvement
- Oversee complaint handling, investigation, trending, and global regulatory reporting including MDR and MDV
- Establish quality objectives and monitor key performance metrics for product quality
- Partner with cross-functional teams to resolve complex product quality issues and drive closure
- Manage Complaint Investigation Laboratory resources, budget, and capital needs
Requirements
- Bachelor's degree in engineering or science
- 8+ years in quality, R&D, or cGxP-regulated environment
- Strong technical foundation in post-market quality or product development
- 3+ years direct management experience with technical teams
- Knowledge of medical device regulations (21 CFR, ISO 13485, ISO 14971)
- Proficiency in Microsoft Office and statistical analysis software
Compensation: $118,000–$196,700 USD base annual
$118k - $196.7k
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