Quality Manager

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

At Volk, we are dedicated to eliminating preventable blindness through every aspect of our work. As a globally respected organization, we are known for delivering exceptional, concierge-level service to ophthalmic practitioners and customers.

Company: Volk

Job Type: Regular / Permanent

Role Type: Full time

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
• 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