Medical Device Quality Engineer — Lean Six Sigma, Flexible

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

Benefits offered by this job

Competitive salary with bonus

401(k) match

Medical, dental & vision coverage

Health Savings Account

Paid holidays and vacation

Flexible work environment

Learning and development

Career growth

Inclusive culture

Job summary

Lubrizol Corporation in Corona, CA is seeking a Quality Engineer to shape and maintain quality systems for medical device products. You will develop QA controls, write validation protocols, and lead CAPA and improvement initiatives.

The role requires a Bachelor's degree and 2+ years in manufacturing or quality with medical devices, including FMEA and DOE experience. On-site position with a competitive salary and bonus potential.

Qualifications

• Bachelor’s degree required.
• 2+ years in manufacturing, engineering or quality in industrial setting.
• Experience in medical device industry.
• Experience with FMEA and root cause analysis.
• Experience implementing CAPA and process controls.
• Experience with DOE, process analysis, and capability assessments.
• Experience with verification and validation activities.
• Ability to establish Control Plans and FMEAs.

Responsibilities

• Develop and drive effective quality assurance controls.
• Write validation and verification plans and protocols; assist IQ/OQ/PQ activities.
• Support process and/or product improvement projects.
• Investigate material nonconformances and coordinate resolutions.
• Analyze data with statistical tools and perform root cause analysis.
• Drive CAPA processes and improve process capabilities.
• Create or revise Control Plans for new and existing products.
• Support supplier quality and customer requests.
• Conduct quality audits and corrective actions.

Skills

Root cause analysis

FMEA

CAPA

SPC

DOE

Verification & Validation

Control Plans

12 quality tools

Education

Bachelor’s Degree

Tools

Minitab

JMP

Statgraphics

Job description

Lubrizol Corporation in Corona, CA is seeking a Quality Engineer to shape and maintain quality systems for medical device products. You will develop QA controls, write validation protocols, and lead CAPA and improvement initiatives.

The role requires a Bachelor's degree and 2+ years in manufacturing or quality with medical devices, including FMEA and DOE experience. On-site position with a competitive salary and bonus potential.