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Quality Engineer

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Date: Nov 20, 2022

Location: Corona, CA, US, 92879

Company: Lubrizol Corporation

About Lubrizol  
The Lubrizol Corporation, a Berkshire Hathaway company, is committed to enabling a sustainable future. Our unmatched science unlocks immense possibilities at the molecular level, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better. Our solutions are used by people every day, improving billions of lives around the world. 

We value diversity in professional backgrounds and life experiences. By enabling a consistent, unbiased, and transparent recruitment process, Lubrizol seeks to create a positive experience for candidates so we can get to know them at their best. We recognize unique work and life situations and offer flexibility, ensuring our employees feel engaged and fulfilled in every aspect of life. 

 

As the Quality Engineer, you’ll support to the manufacturing and quality processes for medical components. The Quality Engineer provides engineering support of our quality systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards. You will provide product engineering support by assessing risk and process capabilities and developing and implementing effective quality assurance controls. You will use a “hands-on” approach to problem solving, problem investigation and data mining.

 

Essential Duties & Responsibilities

  • Develops, writes, and assists with the implementation of effective quality assurance controls
  • Writes validation and verification plans and protocols; assists with IQ/OQ/PQ activities, including finalizing reports.
  • Coordinates the identification, assignment, monitoring, and completion of process and/or product improvement projects.
  • Partners with the operations and engineering functions to coordinate pilot production of new products.
  • Coordinates the reporting, analysis, and resolution of material nonconformance occurrences.
  • Applies 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).
  • Conducts risk analysis; creates or revises control plans for new and existing products.
  • Completes projects in a manner consistent with corporate objectives.
  • Provides support in the rapid resolution of product complaints and/or safety issues.
  • Provides quality assurance appraisal of suppliers.
  • Conducts quality process and product audits and develop responsive corrective action plans.
  • Applies technical writing skills to document current practices to meet quality requirements necessary for QMS.
  • Supports completion of customer requests (e.g., supplier surveys, EU MDR compliance declarations, etc.).
  • Provides specific support for operational quality management system programs.
  • Performs other duties as assigned. 

 

Required Education, Skills & Experience

  • Bachelor’s Degree in an engineering or technical discipline
  • At least 2 years’ experience in medical device industry.
  • Understanding of ISO 13485, FDA 21CFR Part 820, cGMP and working knowledge of regulations (e.g., EUMDR, REACH, RoHS, etc.)
  • Solid understanding of the fundamentals of statistics. Familiarity with SPC.
  • Experience and familiarity with tools of root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA).
  • Experience 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.
  • Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
  • Experience with quality management systems.
  • Excellent written and verbal communication skills. Ability to lead and influence others to drive change.
  • Excellent project management skills.
  • Experience with Lean or Six Sigma manufacturing principles.
  • CQE Certification a plus.

 

Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Planand so much more!

Visit http://benefits.lubrizol.com to learn more.

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If you’re interested in the position, we encourage you to apply. Lubrizol is always looking for candidates who embody our cultural beliefs in everything they do. If you’re All In, Lead Decisively, Take Action, Think External, and can Be Courageous, Lubrizol could be the place for you.


Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles

Job Segment: QA, Quality Assurance, Lean Six Sigma, Quality Engineer, Medical Device Engineer, Technology, Quality, Management, Engineering