Quality Engineer

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Shape the Future with Us. At Lubrizol, we’re transforming the specialty chemicals market through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact—on your career, your community, and the world around you.

Job Type: Full-time / On-site

Shift +

Hours:

1st Shift

As a Quality Engineer you'll be at the forefront of our innovation, driving specialty chemical solutions forward. You'll collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing, and enhance modern life.

The Quality Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics and goals. Specifically, the Quality Engineer position is the process owner for the site CAPA program, process validations, Customer Complaints, NCRs, CAPAs, Internal Audits, and assigned New Product Development programs.

In this role, you will:

• Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA’s, Control Plans, Procedure and Process development
• Supports investigation and resolution of NCRs and CAPAs.
• Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
• Owner of applicable Quality Systems related NCR/CAPA’s.
• Role is subject matter expert and technical advisor on the CAPA element of the site quality management system.
• Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.
• Analyzes inspection and testing processes, mechanisms and equipment.
• Develops and/or reviews product, process test equipment and/or software validation and qualification protocols and tracks execution of protocols in support of project timelines.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
• Observe and promote Company standards and policies on safety, quality and productivity.

• Successful completion of four-years of high school, or equivalent, plus completion of four years of college with a bachelor’s degree, preferably in engineering or science arena.
• Three to seven years of experience in Medical Device Industry (preferred)
• Knowledge of ISO 13485:2003, FDA 21 CFR Part 820 (preferred)
• Experience with Statistical Process Control and Process Validation (preferred)
• Certified Quality Engineer or Auditor (ASQ) (preferred)
• Six Sigma Green or Black Belt (preferred)
• Experience with Process, Product and/or Software Validation (preferred)

• Great technical writing skills applicable to the medical device industry or equivalent regulated industry (preferred)
• 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

At Lubrizol, we’re committed to providing a safe, inclusive, and empowering environment where you can do your best work—whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include:

• Standing, walking, or operating equipment for extended periods
• Working in a lab or manufacturing setting with appropriate PPE provided
• Use of computers and digital tools in an office or hybrid environment
• Occasional lifting or movement of materials
• Adherence to rigorous safety protocols and ergonomic standards
• This physical demand level for this job is considered light with occasionally lifting 10-25 pounds. Exposure to lifting more than 25 pounds is rare (if ever).
• The employee may frequently be subject to dynamic standing/walking and using hands to finger or…