Senior Quality Engineer

Shape the Future with Us. At Lubrizol, we’re transforming the Specialty Chemical and Medical Solutions industries through science, sustainability, and a culture of inclusion.

Job Type: Full Time / On-Site

Salary Range: $135,000 - $145,000 with a 6% Bonus

As the Senior Quality Engineer you'll be at the forefront of our innovation by providing tactical support to the development of new manufacturing and quality processes.

The Quality Engineer provides engineering support of the company’s quality systems, ensuring compliance with ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards. The Engineer assesses risk, process capabilities, develops and implements quality assurance controls, and takes a “hands‑on” approach to problem solving, investigation and data mining.

• Develop, write, and assist with the implementation of effective quality assurance controls.
• Write validation and verification plans and protocols, assist with IQ/OQ/PQ activities, including final reports.
• Coordinate identification, assignment, monitoring, and completion of process and/or product improvement projects.
• Work with operations and engineering functions to coordinate pilot production of new products.
• Coordinate reporting, analysis, and resolution of material nonconformance occurrences.
• Apply statistical and quality tools to analyze data and perform root cause analysis (Fishbone Diagram, 6M, 5
  
  Whys), execute CAPA processes and improve process capabilities (5S, Lean, Six Sigma, DOE, SPC).
• Conduct risk analysis, create or revise control plans for new and existing products.
• Complete projects in a manner consistent with corporate objectives.
• Provide support in the rapid resolution of product complaints and safety issues.
• Provide quality assurance appraisal of suppliers.
• Conduct quality process and product audits and develop responsive corrective action plans.
• Technical writing to document current practices to meet quality requirements necessary for QMS.
• Support completion of customer requests (Supplier surveys, EU MDR compliance declarations, etc.).
• As directed, provide specific support for operational quality management system programs.
• Perform other required duties as needed in addition to essential duties and responsibilities described above.

• Bachelor’s degree in engineering or related technical discipline.
• 2+ years of experience in manufacturing, engineering, or quality.
• Experience in medical device industry.
• Experience and familiarity with tools for root cause analysis and defect analysis, including FMEA.
• Experience with 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.
• Experience with SPC.
• Able to apply statistical methods, and analysis using statistical software such as Minitab, JMP or Statgraphics.
• Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
• 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.

• 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.

• Competitive salary with performance-based bonus plans.
• 401(k) match + age‑weighted defined contribution.
• Comprehensive medical, dental & vision coverage.
• Health savings account (HSA).
• Paid holidays, vacation, and parental leave.
• Flexible work environment.
• Learning and development opportunities.
• Career and professional growth.
• Inclusive culture and vibrant community engagement.