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Senior Quality Engineer

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Location: Remote
Compensation: Salary
Reviewed: Tue, Oct 27, 2026
This job expires in: 30 days
Job Category: Information Technology
Weekly Hours: Full Time
Employer Type: Employer
Career Level: Experienced
Education Level: Bachelors
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Job Summary

To support the advancement of precision medicine, the full-time Senior Quality Engineer will manage the implementation and maintenance of quality management systems and software development life cycle tools, perform computer system validation activities, and support medical device software design controls in compliance with regulatory requirements.

Key responsibilities
  • Manage the implementation and maintenance of QMS software and SDLC tools, ensuring compliance and quality processes
  • Perform and support computer system validation activities, collaborating with software engineering teams to assure quality deliverables
  • Support medical device software design controls activities, including writing and reviewing Design History File deliverables
Required qualifications
  • BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines
  • 5+ years in a quality role in the medical device/IVD (or FDA regulated) industry
  • Experience with FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, and 21 CFR Part 11
  • Familiarity with SDLC tools such as JAMA, JIRA, Atlassian, and eTQ
  • Experience with Agile/Scrum/iterative software development methodology

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