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Quality Leader: Medical Device QMS & Compliance
Job in
Mentor, Lake County, Ohio, 44060, USA
Listed on 2026-08-08
Listing for:
Volk Optical Inc.
Full Time
position Listed on 2026-08-08
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Volk Optical Inc. seeks a Quality Manager to lead the Quality team and drive excellence in a regulated manufacturing setting. You will oversee the QMS, ensure compliance with ISO 13485 and FDA QSR 21 CFR 820, and coordinate internal and supplier audits while reporting critical quality metrics to senior leadership.
Ideal candidates have a strong background in CAPA, risk management, design controls, and root cause analysis, with proven cross-functional influence and data-driven decision making.
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