Quality Manager

Halma plc; Mentor (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Volk, a leading ophthalmic lens brand under Halma, seeks a Quality Manager in Mentor, Ohio. You will lead the Quality team, drive continuous improvement, and ensure ISO 13485 and FDA QSR compliance. You will own audits (ISO, FDA, customer), CAPA, and data-driven quality metrics.

You will influence cross-functional teams and guide risk management, design controls, and verification/validation activities to ensure top quality and regulatory adherence.

Qualifications

• Bachelor’s degree in Engineering or related field; advanced degree preferred.
• 5+ years in quality engineering/management in regulated manufacturing.
• Strong knowledge of ISO 13485, FDA QSR, and medical device compliance.
• Experience with CAPA, nonconformance investigations, and root cause analysis.
• Familiarity with design controls, risk management (FMEA), verification and validation.
• Experience supporting audits and regulatory inspections.
• Excellent analytical, problem-solving, and data-driven decision skills.
• Ability to drive cross-functional influence across the organization.

Responsibilities

• Lead and develop the Quality team to drive accountability and continuous improvement.
• Lead and maintain the QMS in compliance with ISO 13485 and FDA requirements.
• Serve as Management Representative for ISO and regulatory audits.
• Analyze quality data and trends; report metrics to leadership.

Skills

ISO 13485

FDA QSR (21 CFR 820)

CAPA

Root cause analysis

Design controls

Risk management (FMEA)

Verification & Validation

Audits & regulatory inspections

Data-driven decision making

Cross-functional collaboration

Analytical problem solving

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Job description

## 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