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Regulatory Quality Specialist: CAPA, Audits & Risk

Job in Mentor, Lake County, Ohio, 44060, USA
Listing for: Brooksource
Full Time position
Listed on 2026-07-27
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 52000 - 74000 USD Yearly USD 52000.00 74000.00 YEAR
Job Description & How to Apply Below

Brooksource is seeking an Associate Quality Specialist to administer the site’s quality functions, ensuring compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and related standards. This role coordinates document control, site record retention, calibration and inspection activities.

You will facilitate customer complaint investigations, support audits, supplier quality, and risk management, and help track quality data for management review purposes.

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