Quality Director, Medical Devices & Compliance

Volk Optical Inc.; Mentor (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Volk Optical Inc. is seeking a seasoned Quality leader to drive the Quality Management System and regulatory compliance across our medical device manufacturing environment.

You will lead the quality team, manage CAPA activities, and ensure robust data-driven decision making to meet ISO 13485 and FDA QSR 820 requirements. As the Management Representative, you will coordinate audits (ISO, FDA, customer) and oversee continuous improvement initiatives, collaborating with cross-functional teams to

Qualifications

• Bachelor’s degree in engineering; advanced degree preferred.
• 5+ years in quality engineering/quality management in regulated manufacturing.
• Solid knowledge of ISO 13485 and FDA QSR 21 CFR 820.
• Experience with CAPA investigations and root-cause analysis.
• Knowledge of design controls and risk management (FMEA).
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, and data-driven decision skills.
• Ability to influence outcomes across functions.

Responsibilities

• Lead and develop the Quality team with accountability and continuous improvement.
• Maintain and improve the QMS in compliance with ISO 13485 and FDA QSR 820.
• Serve as Management Representative for ISO and certification audits; lead audits.
• Lead internal and external audits (ISO, FDA, customer inspections).
• Analyze quality data and report metrics to leadership for visibility and accountability.

Skills

Quality leadership

Regulatory compliance

CAPA investigations

Root cause analysis

FDA QSR 820

Risk management

Design controls

Audits management

Data analytics

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Job description

Volk Optical Inc. is seeking a seasoned Quality leader to drive the Quality Management System and regulatory compliance across our medical device manufacturing environment.

You will lead the quality team, manage CAPA activities, and ensure robust data-driven decision making to meet ISO 13485 and FDA QSR 820 requirements. As the Management Representative, you will coordinate audits (ISO, FDA, customer) and oversee continuous improvement initiatives, collaborating with cross-functional teams to