Quality Supervisor, Medical Device

Lubrizol Corporation; Corona (CA); Hybrid; USD 120,000 - 125,000; Full time

Benefits offered by this job

Competitive salary with performance‑dr

401(k) match + Age-Weighted Defined CD

Health Savings Account (HSA)

Paid holidays, vacation, and parental 

Job summary

Lubrizol Corporation in Corona, CA, seeks an experienced Quality Management System (QMS) Supervisor to lead the site’s QMS program, including internal audits, management reviews, and regulatory alignment.

You’ll drive KPI development, oversee audit programs, and coordinate with cross-functional teams to ensure compliance with ISO 13485, 21 CFR 820, and ISO9001. The role is full-time onsite with a strong emphasis on continuous improvement and training.

Qualifications

• 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 ISO 13485 and 21 CFR 820.

Responsibilities

• Responsible and accountable for all site QMS activities to be executed promptly and effectively.
• Establish and sustain the site QMS in line with required industry standards (FDA 21 CFR 820, ISO13485, ISO14001 / ISO 9001 / ISO45001).
• Lead and manage the audit program and ensure nonconformities are corrected and verified.
• Lead and manage customer audits at the site.
• Manage external registrations and liaise with external entities on registration matters.
• Ensure training for the Quality Management System is effective.
• Ensure internal audits are process-based and effective.
• Develop, implement, and manage KPIs related to the QMS.
• Provide inputs for the Management Review Meeting (MRM).
• Work with the Management team on continuous improvement of the QMS.
• Be responsible for the quality training program and compliance with HSES policies.

Skills

Quality Leadership

Audit Programs

Regulatory Compliance

Cross-functional collaboration

Education

HS Diploma or GED

Tools

ISO 13485

21 CFR 820

Job description

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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.

How You’ll Make an Impact

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 21CFR 820, ISO13485, ISO14001 / ISO 9001 / ISO45001).


• 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.

Required Qualifications that Enables Your Success

• 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

Your Work Environment

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.

Benefits that Empower You

• 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 oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you. We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you. Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future. We win because of you. Let’s build the future together.

Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles
Job Segment: Chemical Research, Manager, Business Process, Quality Manager, Engineering, Management, Quality