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Regulatory Compliance Specialist

DHF Design Controls Specialist – Quality Assurance

Job in Boerne, Kendall County, Texas, 78006, USA
Listing for: Stanbio Laboratory, an EKF Diagnostics Company
Full Time position
Listed on 2026-02-18
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
A leading diagnostics firm in Boerne, TX, is seeking a Quality Design Assurance Specialist. This hands-on role involves ensuring compliance with FDA and ISO 13485 requirements by reviewing, remediating, and creating Design History Files (DHF). Candidates should hold a Bachelor’s degree and have four years of relevant experience. Excellent analytical skills and a strong understanding of design control documentation are essential.

The position offers an engaging opportunity to enhance product quality and support regulatory compliance.
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