Senior Quality Engineer

About Lubrizol

The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales, and technical offices around the world and has about 8,000 employees. For more information, visit

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.

Senior Quality Engineer

Franklin, WI

Full-Time

On-Site

Unleash Your Potential. At Lubrizol we're transforming the medical device industry and looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world, and want to make a real impact, we want you on our team.

As a Senior Quality Engineer, you'll be at the forefront of our innovation, driving improvements for different quality systems (CAPA program, customer complaints, nonconformance, internal and external audits, risk management, training, validation and so forth). You'll collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing and enhance modern life. The Senior Quality Engineer is primarily responsible for assuring Quality Systems quality compliance through the development, implementation, improvement, and monitoring of appropriate processes to meet quality/business metrics and goals.

Additionally, this person will be responsible evaluating basic quality standard operations and identifying/leading continuous improvement efforts around the production process, testing, sampling/inspection, and training.

• Manage the development and implementation of methods and procedures for process control, process improvement, testing, and inspection to ensure that products are ideal and functional across the site.
• Support validation activities.
• Generate and analyze reports on defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Collaborate with customers on quality problems, ensure that effective corrective actions are implemented.
• Support/facilitate the change management process.
• Provide Quality expertise in product/production development, customer projects, risk management.
• Develop and maintain documentation in compliance with FDA and ISO requirements.
• Lead investigations of product and process non-­conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
• Train and mentor team members on appropriate processes and best practices.
• Support and participate internal, regulatory and customer audits.
• Perform internal audits.
• Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.
• Act as Quality Lead in the absence of Quality Management.

• Successful completion of a bachelor’s degree, preferably in an engineering (mechanical, biomedical, manufacturing) or science.
• 5+ years of experience in Medical Device or Manufacturing (Injection Molding & Extrusion) industry.
• 5+ years of experience in a regulated industry (pharmaceutical, cosmetic and, medical device) with knowledge of ISO 13485:2016, FDA 21 CFR Part 820.
• Experience with Statistical Process Control and Process Validation.
• Certified Quality Engineer or Auditor (ASQ).
• Six Sigma Green or Black Belt.

• High technical writing skills applicable to the medical device industry or equivalent regulated industry.

• Competitive salary with performance-based bonus plans
• 401K Match plus Age Weighted Defined Contribution
• Com…