Software Quality Assurance Specialist II

2 weeks ago


Maple Grove, Minnesota, United States Boston Scientific Full time
About Boston Scientific
Boston Scientific is a leader in medical science, committed to solving the challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives and create value for our customers.

Job Description:
We are seeking a Software Quality Assurance Specialist II 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

Required Skills and Qualifications:
* Bachelor's level degree or higher in Science/Engineering/Software discipline* Minimum of 2 years of related work experience in software QA and/or computer systems validation* Knowledge of the System Development Life Cycle (SDLC), preferably with automated manufacturing and computerized lab systems* Understanding of 21 CFR Part 11 (electronic records/electronic signature)* Experience supporting manufacturing in regulated industry*

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