Quality Engineer - II
Medtronic Inc
Medtronic's Interventional Cardiology Therapies division seeks a Quality Engineer II to lead post-market surveillance operations in Santa Ana, California. The role encompasses complaint investigations, regulatory submissions, safety reporting, and cross-functional collaboration to ensure product quality and compliance.
Responsibilities
- Lead complaint investigations and conduct trending analysis to identify product risks and field action needs
- Collaborate across functions on complaint investigations, explant analysis, and safety assessments
- Prepare regulatory responses and maintain periodic safety update reports in coordination with teams
- Review design assurance documentation including hazard analysis and risk management files
- Escalate quality issues to leadership with timely, data-driven recommendations
Requirements
- Bachelor's degree in engineering, health science, or technical discipline
- Minimum 2 years engineering or science work experience
- Unrestricted U.S. work authorization at hire; no sponsorship available
- Advanced degree in engineering or science preferred
- Experience with implantable medical devices in regulated industry preferred
- Knowledge of cardiovascular procedures and product development cycles preferred
Vacancy posted 5 days ago
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