Quality ManagerVolk 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 PurposeLead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement aligned with Volk ValuesLead, maintain, and continuously improve the QMS in compliance with ISO 13485, FDA Quality System Regulations (21 CFR §820), and applicable global regulationsServe as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer auditsAnalyze quality data and trends to identify improvement opportunities; develop and report quality metrics to leadership to ensure visibility and accountabilityRequired QualificationsBachelor's degree in Engineering (Electrical, Biomedical, Chemical, Industrial, or related field); advanced degree preferred5+ years of experience in quality engineering or quality management within a regulated manufacturing environmentStrong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR §820), and medical device compliance requirementsExperience with CAPA, nonconformance investigations, and root cause analysis methodologiesKnowledge of design controls, risk management (FMEA), verification, and validation processesExperience supporting audits and regulatory inspectionsStrong analytical, problem-solving, and data-driven decision-making skillsAbility to work cross-functionally and influence outcomes at multiple levels of the organization