Quality Manager, Medical Devices & Compliance

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

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.