Senior Quality Engineer — Med Device, ISO 13485 Leader

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

Benefits offered by this job

Bonus plan

401(k) match

Comprehensive medical, dental & vision

Health Savings Account (HSA)

Paid holidays, vacation, and parental/

Flexible work environment

Learning and development opportunities

Career and professional growth

Inclusive culture and community

Job summary

Lubrizol is seeking a Senior Quality Engineer to lead quality systems, risk management, validation, and process controls across the product lifecycle. You will drive regulatory compliance to ISO 13485, CFR 21 Part 820, and ISO 14971 while mentoring engineers and partnering with cross-functional teams.

You’ll own CAPA investigations, validation strategies, and supplier quality initiatives, shaping continuous improvement and operational excellence in a fast-paced, on-site environment in Corona, CA.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 5+ years of progressive experience in Quality Engineering within a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR.
• Experience leading verification and validation activities.
• Experience with CAPA, nonconformance management, risk management.
• Experience with capability analysis, SPC, MSA, sampling plans, statistical methodologies.
• Experience with control, document control, and quality management system processes.
• Experience developing and maintaining Control Plans, FMEAs, PPAPs, inspection plans.

Responsibilities

• Lead QA systems development and continuous improvement to ensure product quality and compliance.
• Provide leadership for NPI, process development, and technology transfers.
• Develop and approve validation protocols (IQ/OQ/PQ) and reports.
• Lead investigations for nonconformances, CAPA, and corrective actions.
• Coordinate risk management activities per ISO 14971.
• Mentor Quality Engineers and cross-functional teams.
• Drive supplier quality programs and audits.
• Prepare for regulatory inspections and customer audits.

Skills

Quality Engineering

Regulatory Compliance

Risk Management

Validation

CAPA

FMEA

DOE

Statistical Analysis

Minitab

Root Cause Analysis

Education

Bachelor’s degree in engineering or related technical discipline

Master's degree (preferred)

Tools

Minitab

JMP

Job description

Lubrizol is seeking a Senior Quality Engineer to lead quality systems, risk management, validation, and process controls across the product lifecycle. You will drive regulatory compliance to ISO 13485, CFR 21 Part 820, and ISO 14971 while mentoring engineers and partnering with cross-functional teams.

You’ll own CAPA investigations, validation strategies, and supplier quality initiatives, shaping continuous improvement and operational excellence in a fast-paced, on-site environment in Corona, CA.