Quality Management Lead – Medical Devices & QMS

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

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.