Quality Manager

VOLK OPTICAL, INC.; Reynolds (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

VOLK OPTICAL, INC. is seeking a Quality leader to spearhead the Quality team, foster a culture of accountability, and drive continuous improvement aligned with Volk values.

You will maintain the QMS in compliance with ISO 13485 and FDA QSR (21 CFR 820) while serving as Management Representative for audits, and you will analyze quality data to identify opportunities for improvement across the organization.

Qualifications

• Bachelor’s degree in Engineering or related field; advanced degree preferred.
• 5+ years in quality engineering/quality management in regulated manufacturing.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and medical device compliance.

Responsibilities

• Lead and develop the Quality team with a focus on accountability and continuous improvement.
• Maintain and continuously improve the QMS in compliance with ISO 13485 and FDA QSR.
• Serve as Management Representative for ISO and certification audits, leading internal and external audits.
• Analyze quality data and trends to identify opportunities and report metrics to leadership.

Skills

Quality leadership

QMS ISO 13485

FDA QSR compliance

CAPA & root cause analysis

Auditing

Data analysis

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; 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

Halma is a global group of life‑saving technology companies with major operations in the UK, Mainland Europe, the USA and Asia Pacific. Our purpose is to grow a safer, cleaner, healthier future for everyone, every day. Halma offers career opportunities for both senior leaders and for graduates.We welcome experienced professionals who are inspired by our purpose, who are entrepreneurial and who want to help take our companies to the next level of growth. Our graduate program offers a unique experience to work in the Halma companies across the world. http://www.halma.com