Quality Supervisor, Medical Device

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Shape the Future with Us. At Lubrizol, we’re transforming the Specialty Chemical and Medical Solutions industries through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact—on your career, your community, and the world around you.

Job Type: Full Time / Onsite

Salary Range: $120,000 - $125,000 plus 6% bonus.

As a Quality Management System (QMS)
Supervisor
, you'll be at the forefront of our innovation and excellence by driving QMS activities, including internal audits and management review programs. You'll collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing, and enhance modern life. In this role, you will:

• Responsible and accountable for all site QMS activities to be executed promptly and effectively.
• Establish and sustain the site QMS in line with the required industry standards (e.g., FDA 21
  
  CFR 820, ISO
  13485, ISO
  14001 / ISO 9001 / ISO
  45001).
• Lead and manage the audit program and ensure that all nonconformities raised during audits are effectively corrected and independently verified.
• Lead and manage customer audits at the site.
• Manage all external registration requirements to ensure they are met. Liaise with external entities on all matters relating to registration.
• Ensure training for the Quality Management System is effective.
• Ensure internal audits of the QMS are process-based per the audit plan and that they are effective.
• Develop, implement, and manage key leading / lagging performance indicators (KPIs) related to the QMS.
• Ensure all required inputs for the Management Review Meeting (MRM) are reviewed/assessed.
• Work as part of the Management team to share ideas and improve operation, recommending, supporting, and implementing continuous improvement activities for the QMS.
• Be responsible for the quality training program
• Be accountable to conform and comply with all HSES policies and procedures.

• HS Diploma or GED equivalent
• 5+ years experience leading quality management systems within medical device manufacturing, including audit programs
• Experience supervising others
• Experience as an internal and external liaison related to quality
• Familiarity with the ISO 13485 and 21 CFR 820

At Lubrizol, we’re committed to providing a safe, inclusive, and empowering environment where you can do your best work—whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include:

• Standing, walking, or operating equipment for extended periods
• Working in a lab or manufacturing setting with appropriate PPE provided
• Use of computers and digital tools in an office or hybrid environment
• Occasional lifting or movement of materials
• Adherence to rigorous safety protocols and ergonomic standards
• [add site/role specific]

We continuously invest in our facilities and technologies to ensure they support your well-being, productivity, and growth. If you require reasonable accommodation, we are committed to working with you to ensure an inclusive and accessible experience.

• Competitive salary with performance-based bonus plans
• 401(k) match + Age-Weighted Defined Contribution
• Health Savings Account (HSA)
• Paid holidays, vacation, and parental leave

Lubrizol:
Imagined for Life. Enabled by Science. ™ Delivered by You. For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine…