Senior Quality Engineer
Katalyst Healthcares & Life Sciences · Posted Nov 9, 2026
- Richardson, Texas, United States
- Full-time · Senior
- 5+ years
Provide quality engineering support for medical device product development and manufacturing activities.
Responsibilities
- Provide quality engineering support for medical device product development and manufacturing activities.
- Prepare, review, and maintain Quality Plans, protocols, reports, specifications, and engineering documentation.
- Review and approve verification and validation (V&V) protocols and reports.
- Develop and maintain risk management documentation, including DFMEA and PFMEA.
- Support process validation and equipment qualification activities, including IQ, OQ, and PQ.
Requirements
- 5+ years of quality engineering experience in medical devices or regulated life sciences