Senior Quality Engineer - medical device

Job Description

Job Description

InnoTECH Staffing is looking to hire a fulltime permanent Senior Quality Engineer for a medical device company in Waltham, MA.

Senior Quality Assurance Engineer

Clinical-Stage Biomedical Innovation

Location : Mostly On-Site | Occasional Remote Work | Some Domestic Travel

Are you passionate about cutting-edge medical innovation and ready to make a real impact? Our client is a clinical-stage company pioneering biomaterials for neurovascular and trauma conditions, is seeking a Senior Quality Assurance Engineer to join our fast-paced and dynamic team!

This is a hands-on, high-impact role where you'll apply both engineering design assurance and quality expertise to help shape the future of life-saving medical technologies. If you're a problem-solver who thrives in a collaborative, fast-moving environment , this opportunity is for you!

What You'll Do : Quality Assurance

• Be the Quality lead on cross-functional project teams, ensuring compliance with regulatory and design control requirements.
• Develop, implement, and maintain quality management systems (QMS), including supplier management, equipment qualification, documentation, and training (e-QMS).
• Own quality initiatives such as risk management, design verification, product qualification / validation, and clinical product batch release to ensure safe and effective products.

Design Assurance

What You Bring :

BS in Engineering, Science, or related field (advanced degrees a plus!)

4 years of experience in medical device or combination product Quality Assurance

Expertise in ISO 13485, ISO 14971, GMP (CFR 820), and applicable ICH guidelines

Strong analytical, documentation, and problem-solving skills

Excellent communication and collaboration abilities

Ability to flourish in a fast-paced, high-growth environment

Why Join?

Ready to take your career to the next level? Apply today and help us revolutionize medical treatment!