Quality Engineer - Medical Devices, CAPA & DOE

Lubrizol Corporation; Corona (CA); On-site; USD 115,000 - 120,000; Full time

Benefits offered by this job

Performance-based bonus

401(k) match

Health Savings Account (HSA)

Paid holidays & parental leave

Job summary

Lubrizol Corporation in Corona, CA is seeking a Quality Engineer with hands-on QA mindset to ensure compliance with ISO 13485, CFR 21 Part 820, and ISO 14971. You will develop and drive QA controls, and support IQ/OQ/PQ activities and CAPA.

You will analyze data, perform root cause analysis, create control plans, and collaborate with suppliers to ensure product quality while supporting rapid resolution of issues; a strong background in SPC, DOE, FMEA and validation is required.

Qualifications

• Bachelor’s Degree is required.
• 2+ years of experience in manufacturing, engineering or quality in an industrial setting.
• Experience in the medical device industry.
• Experience with root cause analysis and defect analysis including FMEA.
• Experience with process controls and CAPA to drive quality improvement.
• Experience with DOE, process analysis, capability assessments.
• Experience with verification and validation activities.
• Able to develop Control Plans, FMEAs, PPAPs.
• Experience with SPC methods and statistical tools such as Minitab/JMP.

Responsibilities

• Develop, write, and drive effective quality assurance controls.
• Write validation and verification plans and protocols, and assist with IQ/OQ/PQ activities.
• Assist in process and/or product improvement projects.
• Report, analyze and coordinate resolution of material nonconformance.
• Analyze data using statistical and quality tools and perform Root Cause Analysis.
• Drive CAPA processes and improve process capabilities.
• Conduct risk analysis and create/ revise Control Plans.
• Support rapid resolution of product complaints and safety issues.
• Provide quality assurance appraisal of suppliers.
• Conduct audits and develop corrective action plans.
• Support Customer requests (e.g., supplier surveys, EU MDR compliance).
• Support operational quality management system programs.

Skills

Quality Assurance

Root Cause Analysis

CAPA

FMEA

DOE

SPC

Process Validation

Education

Bachelor's Degree

Tools

Minitab

JMP

Statgraphics

Job description

Lubrizol Corporation in Corona, CA is seeking a Quality Engineer with hands-on QA mindset to ensure compliance with ISO 13485, CFR 21 Part 820, and ISO 14971. You will develop and drive QA controls, and support IQ/OQ/PQ activities and CAPA.

You will analyze data, perform root cause analysis, create control plans, and collaborate with suppliers to ensure product quality while supporting rapid resolution of issues; a strong background in SPC, DOE, FMEA and validation is required.