Quality Manager

## Quality ManagerApplylocations: Mentortime type: Full timeposted on: Posted Todayjob requisition id: JR26\_000869Volk 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 accountabilityREQUIRED 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 #J-18808-Ljbffr