Quality Manager
Job in
Mentor, Lake County, Ohio, 44060, USA
Listed on 2026-10-11
Listing for:
Halma plc
Full Time
position Listed on 2026-10-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
Mentor time type:
Full time posted on:
Posted Todayjob requisition :
is the world's leading brand in ophthalmic diagnostic and surgical lenses. Our purpose is to eradicate preventable blindness through all aspects of the work we do. Volk is a highly regarded, global organization and is a subsidiary of Halma, a FTSE 100 company. To support our ongoing growth, we are looking for you!
PRIMARY PURPOSE
* Lead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement aligned with Volk Values
* Lead, maintain, and continuously improve the QMS in compliance with ISO 13485, FDA Quality System Regulations (21 CFR §820), and applicable global regulations
* Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits
* Analyze quality data and trends to identify improvement opportunities; develop and report quality metrics to leadership to ensure visibility and accountability REQUIRED QUALIFICATIONS
* Bachelor’s degree in Engineering (Electrical, Biomedical, Chemical, Industrial, or related field); advanced degree preferred
* 5+ years of experience in quality engineering or quality management within a regulated manufacturing environment
* Strong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR §820), and medical device compliance requirements
* Experience with CAPA, nonconformance investigations, and root cause analysis methodologies
* Knowledge of design controls, risk management (FMEA), verification, and validation processes
* Experience supporting audits and regulatory inspections
* Strong analytical, problem-solving, and data-driven decision-making skills
* Ability to work cross-functionally and influence outcomes at multiple levels of the organization* #volk #LI-MF2
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