Sr. Design Quality and Regulatory Engineer
2 weeks ago
Skills, experience & qualifications required:
- Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred.
- 5+ years in a quality or regulatory engineering role in the Medical Device field or highly regulated industry.
- Minimum 3+ years in a quality or regulatory role with focus on Software.
- Knowledge of and experience in IEC 62304 and experience with software design and validation for medical devices.
- Knowledge of the standards related to medical devices, including ISO 13485, 21 CFR Part 820 and ISO 14971.
- Understanding of design control, disciplined product development processes, regulatory, and quality requirements.
- ISO 13485 inspections and FDA inspections experience preferred.
Job Types: Full-time, Permanent
Benefits:
- Health insurance
-
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