The Lubrizol Corporation · 6 days ago
Senior Quality Engineer
The Lubrizol Corporation is a specialty chemical company focused on delivering sustainable solutions. As a Senior Quality Engineer, you will drive improvements in quality systems and ensure compliance with quality metrics while collaborating with a diverse team to enhance product quality and operational efficiency.
ChemicalInformation TechnologyManufacturingMedicalMedical Device
Responsibilities
Manage the development and implementation of methods and procedures for process control, process improvement, testing, and inspection to ensure that products are ideal and functional across the site
Support validation activities
Generate and analyze reports on defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions
Collaborate with customers on quality problems, ensure that effective corrective actions are implemented
Support supplier qualifications
Support/facilitate the change management process
Provide Quality expertise in product/production development, customer projects, risk management
Develop and maintain documentation in compliance with FDA and ISO requirements
Lead investigations of product and process non‐conformances and out‐of‐specification results and develop effective corrective and preventive actions (CAPA)
Train and mentor team members on appropriate processes and best practices
Support and participate internal, regulatory and customer audits
Perform internal audits
Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes
Act as Quality Lead in the absence of Quality Management
Qualification
Required
Successful completion of a bachelor's degree, preferably in an engineering (mechanical, biomedical, manufacturing) or science
5+ years of experience in Medical Device or Manufacturing (Injection Molding & Extrusion) industry
5+ years of experience in a regulated industry (pharmaceutical, cosmetic and, medical device) with knowledge of ISO 13485:2016, FDA 21 CFR Part 820
Experience with Statistical Process Control and Process Validation
Certified Quality Engineer or Auditor (ASQ)
Six Sigma Green or Black Belt
Preferred
High technical writing skills applicable to the medical device industry or equivalent regulated industry
Benefits
Competitive salary with performance-based bonus plans
401K Match plus Age Weighted Defined Contribution
Competitive medical, dental & vision offerings
Health Savings Account
Paid Holidays, Vacation, Parental Leave
Flexible work environment
Company
The Lubrizol Corporation
The Lubrizol Corporation, a Berkshire Hathaway company, is a science-based company whose specialty chemistry delivers sustainable solutions to advance mobility, improve well-being and enhance modern life.
H1B Sponsorship
The Lubrizol Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (10)
2022 (7)
2021 (4)
2020 (7)
Funding
Current Stage
Late StageTotal Funding
unknown2011-03-15Acquired
Recent News
2025-12-08
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