Senior Corporate Software Quality Engineer

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Date: Sep 28, 2026

Shape the Future with Us.

At Lubrizol, we’re bringing to life the chemistry behind clean water, efficient transportation, reliable infrastructure, critical medicines, and the products people rely on every day through science, sustainability, and a culture of inclusion.

As part of our global team, you’ll be empowered to make a real impact - on your career, your community, and the world around you.

Job Type: Full
-Time / On-Site

Location: Brecksville OH (with a planned move to Wickliffe OH) or Wickliffe, OH

How You’ll Make an Impact

As a Senior Software Quality Assurance Engineer, you will be at the forefront of our quality excellence by establishing confidence in the software and digital systems used to support our Medical Device contract manufacturing operations. You will lead risk-based Computer Software Assurance and Computer System Validation activities and serve as a primary Quality resource for implementation and lifecycle management of the corporate electronic Quality Management System.

You will partner with Quality, Information Technology, business process owners, manufacturing sites, system owners, software suppliers, and implementation partners to ensure that regulated systems are fit for intended use, appropriately controlled, and maintained in a validated state . Oversee, coordinate, and control manufacturing for a team. This includes job assignments, monitoring work activities, resolving problems, performance reviews and related items on a day-to-day basis.

• Lead Risk-based Computer Software Assurance and Computer Systems Validation Activities used in Medical Device Production, Quality Management System Processes, monitoring and measurement and other regulated activities.
• Develop, Improve, Maintain Corporate Software Assurance and Validation processes and procedures for Medical Device Production.
• Oversee Software assessments - regulatory, intended-use, risk and validation.
• Provide Quality Oversight for system configuration, data migration, electronic workflows, audit trails, security roles, access controls, record retention, backup and recovery controls and all software validation activities.
• Collaborate with Business Process Owners, Systems Owners, Information Technology and implementation teams to ensure systems requirements are complete, testable, risk-based, and aligned with approved business processes.

Required Qualifications that Enable Your Success

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or related technical discipline.
• 5+ years of progressively responsible experience in Software Quality Assurance, Computer Software Assurance, Computer System Validation, Quality Engineering, or Quality Systems within the medical-device industry or another highly regulated life-sciences environment.
• Demonstrated experience applying risk-based Computer Software Assurance or Computer System Validation principles to software used in production or Quality Management System processes.
• Experience with and strong working knowledge of 23 CFR 11 requirements for electronic records and electronic signatures.
• Experience with and strong working knowledge of ISO 13485 and ISO 14971 and FDA Quality Management System Regulation 21 CFR Part 820 and the associated processes.
• Experience developing, reviewing, approving, or executing software assurance and validation deliverables, including requirements, risk assessments, validation plans, test evidence, traceability matrices, deviation records, and final reports.
• Working knowledge of GAMP 5 principles and risk-based lifecycle approaches for configured, commercial, cloud-based, or enterprise…