Quality Engineer

Lubrizol - Corona, CA

Full-time - Mid Level

Corona, CA

5,001-10,000 employees

Chemical Manufacturing

About the position

The Quality Engineer at Lubrizol Corporation plays a crucial role in supporting the development of new manufacturing and quality processes. This position involves ensuring compliance with various quality standards, providing engineering support for quality systems, and implementing effective quality assurance controls. The role requires a hands-on approach to problem-solving and data analysis, contributing to the overall quality and safety of products.

Responsibilities

• Develop, write, and assist with the implementation of effective quality assurance controls
• Write validation and verification plans and protocols, assist with IQ/OQ/PQ activities, including finalize reports
• Coordinate the identification, assignment, monitoring, and completion of process and/or product improvement projects
• Work with the operations and engineering functions to coordinate pilot production of new products
• Coordinate the reporting, analysis, and resolution of material nonconformance occurrences
• Apply statistical and quality tools to analyze data and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys)
• Execute CAPA processes and improve process capabilities (e.g., 5S, Lean, 6 Sigma, DOE, SPC)
• Conduct risk analysis, create or revise Control Plans for new and existing products
• Complete projects in a manner consistent with corporate objectives
• 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
• Technical writing to document current practices to meet quality requirements necessary for QMS
• Support completion of Customer requests (e.g., Supplier surveys, EU MDR compliance Declarations, etc.)
• Perform other required duties as needed in addition to the essential duties and responsibilities described above.

Requirements

• Bachelor's Degree in Engineering or related technical discipline
• 2+ years of experience in manufacturing, engineering or quality
• 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, and product quality improvement
• Experience with DOE
• Experience with verification and validation activities
• Ability to conduct process analysis, and capability assessments
• Able to develop and establish Control Plans, FMEAs, PPAPs
• Experience with SPC
• Able to apply statistical methods, and analysis utilizing statistical software such as 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
• Able to lead and influence others to drive change
• Strong written and verbal communication skills