Job Type: Full-Time / On-Site
Salary: $115,000 - $120,000 with 6% bonus target
How You'll Make an ImpactLubrizol's Quality Engineers ensure our corporate quality standards and compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards. Our QEs provide product engineering support but assessing risk, analyzing process capabilities, and finally, developing and implementing effective quality assurance controls. Our QEs have a "hands-on" approach to problem solving, problem investigation and data mining. In this role, you will:
- Develop, write, and drive effective quality assurance controls
- Write validation and verification plans and protocols, and assist with IQ/OQ/PQ activities, including finalize reports.
- Assist in process and/or product improvement projects.
- Report, analyze and coordinate the resolution of material nonconformance occurrences.
- Analyze data using statistical and quality tools and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys).
- Drive CAPA processes and improve process capabilities (e.g.,5S, Lean, 6 Sigma, DOE, SPC).
- Conduct risk analysis and create, or revise, Control Plans for new and existing products.
- Provide support in the rapid resolution of product complaints and/or safety issues.
- Provide quality assurance appraisal of suppliers.
- Conduct quality process and product audits and develop responsive corrective action plans.
- Support completion of Customer requests (e.g., Supplier surveys, EU MDR compliance Declarations, etc.).
- Provide support for operational quality management system programs
Required Qualifications that Enables Your Success- Bachelor's Degree
- 2 + years of experience in manufacturing, engineering or quality in an industrial setting.
- Experience in medical device industry.
- Experience and familiarity with tools for root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA).
- Experience with developing and implementing process controls, corrective and preventive action (CAPA), that drive quality improvement.
- Experience with Design of Experiments(DOE), process analysis, capability assessments.
- Experience with verification and validation activities.
- Able to develop and establish Control Plans, FMEAs, PPAPs.
- Experience with Statistical Process Control (SPC) methods and analysis utilizing statistical software and visualization tools like 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
Preferred Qualifications that Drive you Forward - Bachelors degree in Engineering or other Technical Discipline
- American Society for Quality Certifications: ASQ, CQE, CQA etc.
- Six Sigma certification: Green Belt, Black Belt etc.
- 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
We continuously invest in our facilities and technologies to ensure they support your well-being, productivity, and growth. If you require reasonable accommodation, we are committed to working with you to ensure an inclusive and accessible experience.
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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