Quality Engineer

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

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Shape the Future with Us. At Lubrizol, we’re transforming the Specialty Chemical and Medical Solutions industries through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact—on your career, your community, and the world around you.

Job Type: Full -Time / On-Site

Salary: $115,000 - $120,000 with 6% bonus target

How You’ll Make an Impact

Lubrizol’s Quality Engineers ensure our corporate quality standards and compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards. Our QEs provide product engineering support but assessing risk, analyzing process capabilities, and finally, developing and implementing effective quality assurance controls. Our QEs have a “hands‑on” approach to problem solving, problem investigation and data mining. In this role, you will:

• Develop, write, and drive effective quality assurance controls
• Write validation and verification plans and protocols, and assist with IQ/OQ/PQ activities, including finalize reports.
• Assist in process and/or product improvement projects.
• Report, analyze and coordinate the resolution of material nonconformance occurrences.
• Analyze data using statistical and quality tools and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys).
• Drive CAPA processes and improve process capabilities (e.g.,5S, Lean, 6 Sigma, DOE, SPC).
• Conduct risk analysis and create, or revise, Control Plans for new and existing products.
• Provide support in the rapid resolution of product complaints and/or safety issues.
• Provide quality assurance appraisal of suppliers.
• Conduct quality process and product audits and develop responsive corrective action plans.
• Support completion of Customer requests (e.g., Supplier surveys, EU MDR compliance Declarations, etc.).
• Provide support for operational quality management system programs

Required Qualifications that Enables Your Success

• Bachelor’s Degree
• 2 + years of experience in manufacturing, engineering or quality in an industrial setting.
• Experience in medical device industry.
• Experience and familiarity with tools for root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA).
• Experience with developing and implementing process controls, corrective and preventive action (CAPA), that drive quality improvement.
• Experience with Design of Experiments(DOE), process analysis, capability assessments.
• Experience with verification and validation activities.
• Able to develop and establish Control Plans, FMEAs, PPAPs.
• Experience with Statistical Process Control (SPC) methods and analysis utilizing statistical software and visualization tools like Minitab, JMP or Statgraphics.
• Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
• Experience with quality management systems.
• Experience with Lean, or Six Sigma manufacturing principles

Preferred Qualifications that Drive you Forward

• Bachelors degree in Engineering or other Technical Discipline
• American Society for Quality Certifications: ASQ, CQE, CQA etc.
• Experience with FMEA, 5 Why Analysis, Fishbone Diagrams, Fault Tree Analysis, and statistical analysis.

Your Work Environment

At Lubrizol, we’re committed to providing a safe, inclusive, and empowering environment where you can do your best work—whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include:

• Standing, walking, or operating equipment for extended periods
• Working in a lab or manufacturing setting with appropriate PPE provided
• Use of computers and digital tools in an office or hybrid environment
• Occasional lifting or movement of materials
• Adherence to rigorous safety protocols and ergonomic standards

We continuously invest in our facilities and technologies to ensure they support your well-being, productivity, and growth. If you require reasonable accommodation, we are committed to working with you to ensure an inclusive and accessible experience.

Benefits that Empower You

• Competitive salary with performance-based bonus plans
• 401(k) match + Age-Weighted Defined Contribution
• Health Savings Account (HSA)
• Paid holidays, vacation, and parental leave

Lubrizol: Imagined for Life. Enabled by Science. ™ Delivered by You.

For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you.

We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you.

Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future.

We win because of you. Let’s build the future together.

Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles
Job Segment: Quality Engineer, Six Sigma Black Belt, Medical Device Engineer, Lean Six Sigma, Six Sigma, Engineering, Management