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Senior Software Quality Engineer – Medical Device QMS Lead

Job in Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listing for: Gener8 | The RND Group
Full Time position
Listed on 2026-08-14
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 160000 USD Yearly USD 110000.00 160000.00 YEAR
Job Description & How to Apply Below

Gener8 | The RND Group in Indianapolis, IN is seeking a Senior Quality Systems Engineer to maintain and improve the QMS, ensuring FDA QSR, ISO 13485, IEC 62304, and ISO 14971 compliance across software development life cycles.

The role includes assessing client QMS documents and Design History Files, writing procedures, and providing training to internal project teams and clients, with occasional travel.

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Position Requirements
10+ Years work experience
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