QMS Quality Leader - Medical Devices

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

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.