Senior Quality Engineer
Job Summary
Bridging the gap between Agile development and medical device regulations, the full-time Senior Quality Engineer will manage the end-to-end design control process for software quality and compliance in digital health solutions, ensuring safety and security standards are met.
Key Responsibilities
- Apply global regulatory standards to daily development activities and implement validation frameworks within the Quality Management System
- Participate in software architecture reviews and facilitate comprehensive risk management activities, ensuring safety and privacy principles are integrated
- Manage the Design History File and support the organization during internal and external audits as a subject matter expert for software processes
Required Qualifications
- Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
- 5-8 years of experience in quality engineering or product development within the medical device industry
- Certifications preferred: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt
Complete Job Description
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