Quality Lead - Medical Devices & Regulatory Compliance

Halma p.l.c; Mentor (OH); On-site; USD 95,000 - 150,000; Full time

Job summary

Volk, a世界-leading ophthalmic diagnostics brand and a subsidiary of Halma, seeks a senior Quality leader to drive the Quality Management System and regulatory compliance. You will oversee CAPA, audits, and continuous improvement while coordinating cross-functionally with manufacturing and engineering teams.

The role requires extensive experience in regulated medical device environments, strong data analytics, and the ability to influence outcomes at multiple levels of the organization.

Qualifications

• 5+ years of experience in quality engineering or quality management within a regulated manufacturing environment.
• Strong knowledge of ISO 13485 and FDA Quality System Regulations (21 CFR §820).
• Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
• Knowledge of design controls, risk management (FMEA), verification, and validation processes.

Responsibilities

• Lead and develop the Quality team, fostering accountability and collaboration.
• Maintain and continuously improve the QMS in accordance with ISO 13485 and FDA 21 CFR §820.
• Serve as Management Representative for ISO and certification audits (internal, external, ISO, FDA, customer).
• Analyze quality data and trends to identify improvements and report metrics to leadership.

Skills

Quality engineering

Regulatory compliance

CAPA

Root cause analysis

Data-driven decision making

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Volk, a世界-leading ophthalmic diagnostics brand and a subsidiary of Halma, seeks a senior Quality leader to drive the Quality Management System and regulatory compliance. You will oversee CAPA, audits, and continuous improvement while coordinating cross-functionally with manufacturing and engineering teams.

The role requires extensive experience in regulated medical device environments, strong data analytics, and the ability to influence outcomes at multiple levels of the organization.