Quality Manager

halma· Volk Optical, Inc.
Apply Now ↗
📍 MentorFull time

About this role

 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; experience in medical manufacturing
  • 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

Not the right fit?  Let us know you're interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!

Frequently Asked Questions

Is the salary disclosed for the Quality Manager position at halma?
The salary for this Quality Manager role at halma is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Quality Manager position at halma located?
This Quality Manager role at halma is based in Mentor. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Quality Manager role at halma full-time or part-time?
This is listed as a Full time position. It is posted as a Quality Manager role in the Volk Optical, Inc. department at halma.
Which team or department does the Quality Manager at halma belong to?
This Quality Manager position is part of the Volk Optical, Inc. department at halma. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality Manager position at halma?
Click the "Apply Now" button on this page. You will be redirected to halma's official application portal hosted on workday where you can submit your application directly.
When was the Quality Manager job at halma posted?
This Quality Manager position at halma was posted on Aug 27, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Manager
halma
Apply for this role ↗

You'll be redirected to halma's official application page on Workday.