Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight
Job Summary
Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight.
Ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
The salary range for this position is: $157,590.00 - $203,940.00.
Matching Summary
Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight.
Salary
Base: $157,590.00 - $203,940.00; Bonus/Equity: Discretionary annual bonus, discretionary stock-based long-term incentives; Benefits: Paid time off, company-sponsored medical, dental, vision, and life insurance plans
Skills & Requirements
Must-have
Design controls
Risk management
ISO 13485
ISO 14971
FDA 21 CFR Part 4
Combination product development
Nice-to-have
Strong project management
Process improvement capabilities
Statistical methods
Continuous improvement
Key Requirements
Bachelor's degree in Engineering or scientific discipline with at least 8 years of relevant experience, OR Master's degree with at least 6 years of relevant experience
Demonstrated experience in Quality Assurance for medical devices and/or drug-device combination products
At least 10 years of experience supporting combination products