Quality Engineer for Medical Devices

1 week ago


Maple Grove, Minnesota, United States Boston Scientific Full time
Company Overview
Boston Scientific is a global leader in medical science, dedicated to advancing science for life. We are committed to solving the challenges that matter most, united by a deep caring for human life. Our innovative medical solutions improve patient lives, create value for our customers, and support our employees and the communities we operate in.

Job Description:
We are seeking a Quality Engineer for Medical Devices to join our team. As a key member of our quality assurance department, you will be responsible for developing, establishing, and maintaining software quality assurance methodologies, systems, and practices that meet regulatory requirements. You will also serve as a quality representative to improve awareness, visibility, and communication on quality initiatives.

Your Responsibilities Will Include:
* Working within a team of software quality assurance engineers to support manufacturing, laboratory, R&D, and IT systems* Actively contributing to all aspects of software quality assurance activities in an FDA-regulated medical device environment* Performing independent reviews of design, development, and testing of software/firmware used in Boston Scientific product lines throughout their entire system development life cycle* Reviewing and approving documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix, and qualification reports along with support documentation for equipment qualification

Benefits:
* Competitive salary* Comprehensive benefits package* Opportunities for career growth and professional development* Collaborative and dynamic work environment*

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