Volk 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; experience in medical manufacturing
• 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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