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Quality Assurance Specialist for Medical Devices
2 weeks ago
We are seeking a highly skilled Senior Manufacturing Quality Engineer to join our team at SciPro. This role will be responsible for ensuring that our medical device design and development processes comply with applicable regulatory and industry standards.
Key Responsibilities- Provide quality engineering expertise to support design and development activities in compliance with ISO 13485 and FDA QSR requirements.
- Support risk management activities per ISO 14971, including hazard analysis, FMEA, and risk-benefit analysis.
- Ensure compliance with software lifecycle processes per ISO 62304, collaborating with software engineering teams to establish and maintain software validation and verification processes.
- Oversee compliance with usability engineering requirements per ISO 62366, working with human factors specialists and user experience teams.
- Bachelor's degree in Engineering, Quality, or a related field.
- Minimum of 4 years of experience in medical device design quality engineering.
- Strong knowledge of ISO 13485, ISO 62304, ISO 62366, ISO 60601-1, ISO 60601-2-37, ISO 14971, and medical device labeling regulations.
- Experience working with FDA QSR (21 CFR Part 820) and international regulatory requirements.
