Job Type: Full-Time / On-Site
Salary: $135,000 - $145,000 with 6% bonus target
How You'll Make an ImpactThe
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.
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 EnvironmentAt 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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