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.

Quality Engineer

Victor, Montana

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 Quality Engineer, you'll be at the forefront of our innovation of assuring the quality and compliance of our products and quality systems; through the development, implementation and monitoring of appropriate processes, tools, metrics and goals. Specifically, the Quality Engineer is the process owner and is responsible for the SiMatrix Internal Audit System, Supplier Quality, and Quality Systems Training Programs

• Own applicable Quality Systems related NCR/CAPA’s.
• Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
• Develop, implement, monitor and improve the internal Quality Systems in support of site objectives.
• Develop and deliver training in support of implementing the Quality System.
• Support new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA’s, Control Plans, etc.
• Understand ISO 13485 and FDA QSR requirements and apply them to applicable processes.
• Apply ability to analyze product and process quality data to identify and make recommendations for meeting organizational Quality objectives (improved product quality, scrap reduction, complaint reduction, rework reduction, etc.).
• Understand and follow the SOP’s and other work instructions pertaining to the specific area.
• Write validation and qualification protocols and final reports, assisting with IQ/OQ/PQ activities as required.
• Other duties as assigned

• Observe and promote Company standards and policies on safety, quality and productivity.
• Responsible for supply chain regulatory activities (Latex, WEEE, RoHS, REACH, etc.)

• Bachelor’s degree, preferably in the engineering or science arena.
• 3+ years of experience in a quality manufacturing role/environment, or any combination of education and experience that provides equivalent knowledge, skills and abilities.

• Direct Medical Device experience (one-three years.
• Certified Quality Engineer (ASQ).
• Certified ISO 13485 Lead Auditor (ASQ).
• Certified Quality Manager (ASQ).
• Mastery knowledge of ISO 13485:2003 and proficiency knowledge in FDA 21 CFR Part 820.
• Six Sigma Green or Black Belt.
• Lean Manufacturing.
• Experience with Statistical Process Control, Blueprint Aanalysis and Process Validation.

• Knowledge of advanced statistical concepts.
• Demonstrated excellent (written and verbal) communication and effective human interaction skills.
• Flexible to change, and possess a high degree level of integrity and “can do attitude”.
• Willing to work in a team environment and contribute to group goals.
• Ability to receive and provide instructions in a positive manner

• They physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to…