Medical Device Quality Assurance Specialist

1 month ago


Marlborough, Massachusetts, United States Boston Scientific Full time
About the Role:

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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