Senior Quality Engineer
Location:
Watertown, MA (Hybrid)
A growing biotech company focused on advancing drug-device combination products for ocular therapies is seeking a Senior Quality Engineer
to lead quality engineering efforts for its injector platform. This opportunity is offered on a full-time and permanent basis.
Base salary:$110-130K
The Role
In this position, you’ll guide design assurance activities across development and manufacturing, ensuring robust risk management, validation, and documentation practices. You’ll work closely with R&D, Quality, and Engineering teams to maintain compliance with FDA and ISO standards throughout the product lifecycle.
What You’ll Do
- Lead design assurance for injector systems, including risk files and technical documentation
- Review and support equipment qualifications, process validations, and product testing strategies
- Partner with cross-functional teams on design transfer and launch readiness
- Contribute to continuous improvement of quality systems and inspection processes
- Support internal and external audit activities
What You Bring
- Bachelor’s degree in a technical field
- 8+ years of experience in medical device quality, with a strong focus on design assurance
- In-depth knowledge of design controls, risk management, and combination product regulations
- Hands-on experience with validation and statistical analysis tools (e.g., Minitab)
- Comfortable working in a dynamic, collaborative environment
Apply with an update copy of your resume to be considered.
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