Senior Software Quality Engineer
EPM Scientific - Minneapolis, Minnesota, United States, 55400
Work at EPM Scientific
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Overview
$100,000.00/yr - $115,000.00/yr Direct message the job poster from EPM Scientific Software Quality Assurance Engineer - Medical Device (Hybrid, Minneapolis) A leading medical device company is seeking a skilled Software Quality Assurance Engineer to support critical systems across its Maple Grove facility. This role is ideal for someone with a strong background in software QA within an ISO 13485 environment, who thrives in high-stakes, compliance-driven settings. Responsibilities include: * Reviewing test documentation, change controls, and validation artifacts for systems used in manufacturing and laboratory environments * Acting as the final sign-off authority, ensuring all documentation is accurate, error-free, and compliant with FDA and third-party regulatory standards * Supporting systems across multiple divisions, including IC, Cardiology, and PI * Working with a variety of equipment such as lasers, welders, bonders, ovens, incubators, and other lab/manufacturing tools * Maintaining strict compliance and documentation accuracy to avoid regulatory risks Qualifications: * Experience in software quality assurance within a regulated environment
(ISO 13485 Required!) * Familiarity with
computer system validation (CSV) and verification & validation
(V&V) processes * Strong attention to detail and a commitment to documentation excellence * Ability to work cross-functionally and support multiple systems and departments This is a hybrid role based in Minneapolis. If you're interested in learning more or applying, please reach out with your CV and contact adam.tizabi@epmscientific.com Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at EPM Scientific by 2x Get notified about new Senior Software Quality Engineer jobs in
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