Medical Device Quality Assurance Specialist
1 month ago
At Boston Scientific, we're committed to delivering innovative medical solutions that improve patient outcomes.
We're seeking a highly skilled Sr. Design Quality Assurance Engineer to join our team and contribute to the development of safe and effective medical devices.
Responsibilities:
- Provide quality engineering support to operations, product development, and sustaining projects for current products on the market.
- Develop, establish, and maintain quality-engineering methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.
- Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional, and corporate quality goals and priorities.
- Provide quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.
Requirements:
- BS in Mechanical, Electrical, Biomedical Engineering, or related degree.
- 5+ years of Medical Device engineering experience with BS, 3+ years with MS.
- Working knowledge of the FDA, ISO, EUMDR, and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
- Travel approximately 10-15%.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package.
Original Language Code: en
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