Quality Manager

VOLK OPTICAL, INC.; Reynolds (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

VOLK OPTICAL, INC. is seeking a Quality leader to oversee the Quality Management System and drive continuous improvement across the organization. You will lead the Quality team, ensure compliance with ISO 13485 and FDA QSR, and manage audits with customers and regulators.

A systematic, data-driven approach is essential to deliver robust quality outcomes. The role requires strategic leadership, cross-functional influence, and hands-on oversight of CAPA, risk management, design controls, and

Qualifications

• Bachelor’s degree in Engineering or related field with advanced degree preferred.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR §820) and medical device regulatory requirements.
• Experience with CAPA, nonconformance investigations, and root cause analysis.

Responsibilities

• Lead and develop the Quality team to foster accountability, collaboration, and continuous improvement.
• Maintain and improve the QMS in compliance with ISO 13485, FDA QSR, and global regulations.
• Serve as Management Representative for ISO and certification audits (internal and external).
• Analyze quality data and trends to identify improvement opportunities; report metrics to leadership.

Skills

ISO 13485 knowledge

FDA QSR compliance

CAPA

Root cause analysis

FMEA

Design controls

Risk management

Audits (internal/external)

Analytical problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Job description

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 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#volk #LI-MF2Not the right fit? Let us know you're interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!