Senior Quality Engineer – Regulated Medical Devices Leader

The Lubrizol Corporation; Corona (CA); On-site; USD 135,000 - 145,000; Full time

Benefits offered by this job

Competitive salary with bonus plans

401(k) match + defined contribution

Comprehensive medical, dental & vision

HSA

Paid holidays and vacation

Flexible work environment

Learning and development opportunities

Career growth

Inclusive culture

Job summary

The Lubrizol Corporation is seeking a Senior Quality Engineer in California for an on-site role. You will lead quality systems, risk management, validation, and process controls across the product lifecycle to ensure compliance with ISO 13485, CFR 21 Part 820, and EU MDR.

You will mentor teams, drive CAPAs, lead NPI quality activities, and collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to achieve operational excellence.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 5+ years of progressive experience in Quality Engineering or Quality Systems in a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR.
• Experience leading verification and validation activities and CAPA processes.
• Experience with capability analysis, SPC, and statistical methodologies.
• Experience with control and document control within QMS.
• Experience developing FMEAs, PPAPs, inspection plans, and process control strategies.
• Experience with Minitab or JMP for statistical analysis.
• Lean Manufacturing and Six Sigma experience desirable.
• Experience leading supplier quality activities and audits.

Responsibilities

• Lead development and improvement of quality systems, processes, and controls.
• Provide quality leadership for new product introductions and manufacturing transfers.
• Develop and execute IQ/OQ/PQ strategies and validation plans.
• Lead investigations of nonconformances, CAPAs, and root-cause analyses.
• Drive cross-functional problem solving using FMEA, 5 Why, and fault-tree methods.
• Coordinate risk management per ISO 14971 and perform hazard analyses.
• Maintain Process and Design FMEAs, control plans, and inspection strategies.
• Monitor quality metrics to identify trends and reduce variation.
• Mentor Quality Engineers and Technicians; collaborate with Manufacturing, R&D, Regulatory Affairs.
• Lead internal/external audits and support regulatory inspections.

Skills

Quality engineering

Regulatory compliance

CAPA

Root cause analysis

FMEA

DOE

SPC

ISO 13485

FDA CFR 820

Quality systems

Mentor teammates

Cross-functional leadership

Education

Bachelor’s degree in engineering

Master’s degree (preferred)

Tools

Minitab

JMP

Job description

The Lubrizol Corporation is seeking a Senior Quality Engineer in California for an on-site role. You will lead quality systems, risk management, validation, and process controls across the product lifecycle to ensure compliance with ISO 13485, CFR 21 Part 820, and EU MDR.

You will mentor teams, drive CAPAs, lead NPI quality activities, and collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to achieve operational excellence.