Senior Quality Engineer jobs in United States
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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
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H1B Sponsor Likelynote

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

ISO 13485 2016FDA 21 CFR Part 820Statistical Process ControlProcess ValidationCertified Quality EngineerSix Sigma GreenBlack BeltTrainingTechnical WritingCollaborationMentoring

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

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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 Stage
Total Funding
unknown
2011-03-15Acquired

Leadership Team

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Rebecca Liebert
President and CEO
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Keith Corkwell
President, Lubrizol Additives
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Company data provided by crunchbase