Senior Quality Engineer

​​Salary Range: $93,000-$120,000 

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. 

Position Summary

The purpose of this job is to provide support to Company’s Quality System for the Design, Development, and manufacturing of Finished Medical Devices. The Quality Engineer provides engineering support of the Company’s Quality Systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820 and to include Design Control standards. The Quality Engineer provides product engineering support by assessing risk, process capabilities, developing and implementing effective quality assurance controls. The Quality Engineer must have a “hands-on” approach to continuous improvement of the Quality System and implementation and Quality Assurance management of Design Control process, problem solving, problem investigation and data mining.

Essential Duties & Responsibilities

• Develops, writes, and assists with the implementation of effective quality assurance controls
• Writes and reviews validation and verification plans and protocols; assists with IQ/OQ/PQ activities, including finalize reports.
• Compiles and reviews Design History Files and Master Device Records.
• 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, executes CAPA processes, and improves process capabilities (5S, Lean, 6 Sigma, DOE, SPC).
• Completes projects in a manner consistent with corporate objectives.
• Provides support in the rapid resolution of product complaints and/or safety issues.
• Develops and conducts training programs regarding company quality systems.
• Provides quality assurance appraisal of suppliers.
• Performs cost estimating based on labor, material, and variable overhead inputs.
• Conducts quality process and product audits and develops responsive corrective action plans.
• Uses technical writing ability to document current practices to meet quality requirements necessary for QMS for medical devices.
• Provides specific support for operational quality management system programs.
• Perform other duties as assigned.

Required Education, Skills & Experience

• Minimum of a Bachelor’s degree in an Engineering or other Technical discipline (Engineering or Technical)
• At least 5 years’ experience in the medical device industry.
• Experience and familiarity with tools of root cause analysis and defect analysis, including Failure Mode and Effect Analysis for process and product design.
• Experience with developing and implementing process controls, corrective and preventive action, and product and process quality improvement.
• Experience with Design of Experiments.
• Experience with Design History Files, Risk Management and Design output documentation.
• Experience with Verification and Validation activities. Ability to conduct process analysis, and capabilities assessments. Able to develop and establish control plans, process and product design pFMEAs, PPAPs.
• Understanding of ISO 13485 21CFR Part 820, cGMP and proficiency with Design Control requirements.
• Solid understanding of the fundamentals of statistics and familiarity with SPC.
• 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.
• Project planning and management skills.

Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Plan…and 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.