Quality Supervisor, Medical Device

Lubrizol Corporation; Corona (CA); On-site; USD 120,000 - 133,000; Full time

Benefits offered by this job

Bonus plans

401(k) match

Health Savings Account

Paid holidays & leave

Job summary

The Lubrizol Corporation in Corona, CA is seeking a Quality Management System (QMS) Supervisor to lead site QMS activities, audits, and registration processes. You will drive compliance with FDA 21 CFR 820, ISO 13485, ISO14001/9001/45001, and develop KPIs while collaborating with the management team.

The role requires experience in medical device manufacturing and prior supervision, with a focus on continuous improvement.

Qualifications

• Bachelor or equivalent experience not required but minimum education is HS Diploma or GED.
• 5+ years experience leading quality management systems in medical device manufacturing.
• Experience supervising others and liaising with internal/external stakeholders.
• Familiarity with ISO 13485 and 21 CFR 820 required.

Responsibilities

• Lead and manage all site QMS activities, ensuring prompt and effective execution.
• Establish and sustain the site QMS aligned with standards (FDA 21 CFR 820, ISO13485, ISO14001/ISO9001/ISO45001).
• Lead the audit program; address nonconformities and verify corrective actions.
• Lead and manage customer audits at the site and liaison with external registrations.
• Develop, implement, and manage KPIs for QMS and ensure Management Review inputs are ready.

Skills

Quality management

Leadership

Auditing

Regulatory liaison

Education

HS Diploma or GED equivalent

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, Quality, Management