Quality Manager

halma; Mentor (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Volk, a leading ophthalmic diagnostics manufacturer and a subsidiary of Halma, seeks a Quality leader to drive the Quality team and maintain the QMS in line with ISO 13485 and FDA QSR. The role supports ongoing growth in a regulated medical device environment from Mentor, OH.

You will lead audits, analyze quality data, and report metrics to leadership, while collaborating cross-functionally to ensure product quality and regulatory compliance.

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.

Responsibilities

• 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 accountability

Skills

ISO 13485

FDA QSR 21 CFR 820

CAPA

Root cause analysis

Design controls

FMEA

Audits support

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 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 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

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