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Senior Quality Systems Engineer - Medical Devices

Job in Austin, Travis County, Texas, 78716, USA
Listing for: TekWissen ®
Full Time position
Listed on 2026-07-22
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 130000 USD Yearly USD 90000.00 130000.00 YEAR
Job Description & How to Apply Below

Tek Wissen Group seeks a Quality/Regulatory Compliance professional to drive harmonization of QMS procedures across multiple sites and ensure alignment with FDA 21 CFR Part 820, ISO 13485, and EU MDR. The role emphasizes cross-functional collaboration with R&D and Regulatory teams.

The ideal candidate has 5+ years in quality/regulatory roles within the medical device industry, with CQE or equivalent preferred and strong proficiency in SAP/EtQ and Microsoft Office.

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Position Requirements
10+ Years work experience
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