Senior Quality Engineer

Job Type: Full-Time / On-Site

Salary:  $135,000 - $145,000 with 6% bonus target

How You’ll Make an Impact

The Senior Quality Engineer serves as a subject matter expert in quality systems, risk management, validation, process controls, and problem-solving methodologies. This role requires a proactive leader who can influence cross-functional teams, mentor junior engineers, and drive sustainable quality improvements throughout the product lifecycle including compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971.

• Lead the development, implementation, and continuous improvement of quality assurance systems, processes, and controls to ensure product quality and regulatory compliance.
• Provide quality engineering leadership for new product introductions (NPI), manufacturing process development, technology transfers, and process optimization activities.
• Develop, review, approve, and execute validation and verification strategies, protocols, and reports including IQ/OQ/PQ, test method validations, and process validations.
• Lead complex investigations involving nonconformances, complaints, deviations, and CAPAs, ensuring robust root cause analysis and implementation of effective corrective actions.
• Drive cross-functional problem-solving initiatives utilizing advanced quality tools including FMEA, Fishbone Diagrams, 5 Whys, Fault Tree Analysis, DOE, SPC, and statistical analysis methodologies.
• Coordinate and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation activities.
• Lead development and maintenance of Process FMEAs, Design FMEAs, Control Plans, inspection strategies, and process monitoring programs.
• Analyze process capability and quality metrics to identify trends, improve process performance, and reduce variation.
• Serve as a quality representative on product development and manufacturing improvement projects, ensuring quality requirements are effectively integrated into project execution.
• Mentor and provide technical guidance to Quality Engineers, Quality Technicians, and cross-functional teams.
• Partner with Manufacturing, R&D, Regulatory Affairs, Operations, and Supply Chain teams to implement sustainable quality improvements and ensure operational excellence.
• Drive supplier quality initiatives, including supplier qualification, monitoring, audits, performance improvement plans, and resolution of supplier-related quality issues.
• Lead internal and external audits, regulatory inspections, and customer audits, serving as a quality subject matter expert.
• Assess, interpret, and implement changes to regulatory standards, quality system requirements, and industry best practices through document control and change management processes.
• Lead Management Review support activities, quality metrics analysis, and continuous improvement initiatives.
• Support customer and regulatory requests including supplier surveys, technical quality assessments, EU MDR compliance documentation, and quality agreements.
• Identify opportunities to improve efficiency, reduce cost of quality, enhance compliance, and strengthen overall quality system effectiveness.
• Influence organizational quality culture by promoting best practices, accountability, and continuous improvement principles.
• Perform other duties and responsibilities as assigned.

Required Qualifications that Enable Your Success

• Bachelor’s degree in engineering or related technical discipline required;
• 5+ years of progressive experience in Quality Engineering, Manufacturing Engineering, or Quality Systems within a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR, and applicable regulatory requirements.
• Experience leading verification and validation activities, including protocol development, execution, and report approval.
• Experience with CAPA, nonconformance management, complaint investigations, risk management, and process validation activities.
• Experience using root cause investigation methodologies and problem-solving tools.
• Experience with capability analysis, SPC, MSA, sampling plans, and statistical methodologies.
• Experience with  control, document control, and quality management system processes.
• Experience developing and maintaining Control Plans, FMEAs, PPAPs, inspection plans, and process control strategies.
• Experience with  statistical software such as Minitab, JMP, or equivalent analytical tools.
• Experience with  Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Experience leading supplier quality activities, supplier audits, and supplier development initiatives.
• Excellent written, verbal, presentation, and technical communication skills.
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Preferred Qualifications that Drive you Forward

• Master's degree preferred.
• ASQ Certified Quality Engineer (CQE),
• Six Sigma Green Belt, or Six Sigma Black Belt certification preferred.
• Demonstrated ability to mentor, coach, and develop less experienced team members.
• Experience with FMEA, 5 Why Analysis, Fishbone Diagrams, Fault Tree Analysis, and statistical analysis.

Your Work Environment

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

Benefits that Empower You

• 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
  Learn more at benefits.lubrizol.com!

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Lubrizol: Imagined for Life. Enabled by Science. ™ Delivered by You. For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you. We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you. Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future.  We win because of you. Let’s build the future together.