Quality Leader: Medical Device QMS & Compliance

Volk Optical Inc.; Mentor (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Volk Optical Inc. seeks a Quality Manager to lead the Quality team and drive excellence in a regulated manufacturing setting. You will oversee the QMS, ensure compliance with ISO 13485 and FDA QSR 21 CFR 820, and coordinate internal and supplier audits while reporting critical quality metrics to senior leadership.

Ideal candidates have a strong background in CAPA, risk management, design controls, and root cause analysis, with proven cross-functional influence and data-driven decision making.

Qualifications

• 5+ years of quality engineering or quality management within a regulated manufacturing environment.
• Bachelor’s degree in Engineering; advanced degree preferred.
• Strong knowledge of ISO 13485, FDA QSR 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 accountability and continuous improvement.
• Lead, maintain, and improve the QMS in compliance with ISO 13485 and FDA QSR 21 CFR 820.
• Serve as Management Representative for ISO and certification audits, including ISO, FDA, and customer audits.
• Analyze quality data and trends to identify improvement opportunities; report metrics to leadership.

Skills

Quality engineering

Regulated manufacturing

CAPA

FMEA

Root cause analysis

Audits & compliance

Cross-functional collaboration

Data-driven decisions

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Volk Optical Inc. seeks a Quality Manager to lead the Quality team and drive excellence in a regulated manufacturing setting. You will oversee the QMS, ensure compliance with ISO 13485 and FDA QSR 21 CFR 820, and coordinate internal and supplier audits while reporting critical quality metrics to senior leadership.

Ideal candidates have a strong background in CAPA, risk management, design controls, and root cause analysis, with proven cross-functional influence and data-driven decision making.