Senior Quality Engineer: Regulated Medical Devices NPI Lead

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

Benefits offered by this job

Competitive salary with bonus

401(k) match

Health Savings Account (HSA)

Paid holidays, vacation, parentalleave

Job summary

Lubrizol Corporation in Corona, CA seeks a Senior Quality Engineer to lead quality systems, risk management, validation, and process controls across the product lifecycle. You will mentor engineers and coordinate cross-functional teams to ensure ISO 13485, CFR 21 Part 820, and EU MDR compliance.

Responsibilities include SQE leadership for NPI, process development, CAPA investigations, and supplier quality initiatives, with a strong emphasis on data-driven continuous improvement and problem

Qualifications

• Bachelor’s degree in engineering or related technical discipline required.
• 5+ years in Quality Engineering/Quality Systems in a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR and regulatory requirements.
• Experience leading verification and validation activities, including protocol development, execution, and report approval.
• Experience with CAPA, nonconformance management, risk management and process validation.

Responsibilities

• Lead development and continuous improvement of quality assurance systems, processes, and controls for product quality and regulatory compliance.
• Provide quality engineering leadership for NPI, manufacturing process development, and technology transfers.
• Develop and execute IQ/OQ/PQ protocols, validations, reports, and test method validations.
• Lead investigations of nonconformances, complaints, deviations, and CAPAs with root cause analysis.
• Drive risk management per ISO 14971 and lead FMEA/DOE/statistical analysis initiatives.

Skills

Quality engineering

CAPA

Risk management

Process validation

FMEA/DOE/SPC

Regulatory compliance

Team mentorship

Statistical analysis

Education

Bachelor's in engineering

Master's degree preferred

ASQ CQE (preferred)

Tools

Minitab

JMP

Job description

Lubrizol Corporation in Corona, CA seeks a Senior Quality Engineer to lead quality systems, risk management, validation, and process controls across the product lifecycle. You will mentor engineers and coordinate cross-functional teams to ensure ISO 13485, CFR 21 Part 820, and EU MDR compliance.

Responsibilities include SQE leadership for NPI, process development, CAPA investigations, and supplier quality initiatives, with a strong emphasis on data-driven continuous improvement and problem