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Risk & Quality Systems Specialist II; IVDR

Job in Hercules, Contra Costa County, California, 94547, USA
Listing for: Tri-Valley Career Center
Full Time position
Listed on 2026-07-14
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 48216 - 60614 USD Yearly USD 48216.00 60614.00 YEAR
Job Description & How to Apply Below
Position: Risk & Quality Systems Specialist II (IVDR)

Bio-Rad is seeking a qualified professional to support risk management activities, update hazard analyses, and coordinate cross‑functional input for comprehensive risk profiles. The role includes migrating risk files to the eQMS, ensuring metadata accuracy, and addressing gaps relative to IVDR guidance while maintaining adherence to GMP/ISO standards.

The position requires an associate degree and 2+ years in regulated manufacturing or equivalent experience, with strong organizational and

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