Senior Medical Device Quality & Software Assurance Lead

Lubrizol Corporation; Brecksville (OH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive salary with performance‑dr

Job summary

Lubrizol Corporation is seeking a Senior Corporate Software Quality Engineer to lead risk-based software assurance and computer system validation for medical device contract manufacturing operations. You will partner with Quality, IT, and sites to ensure fully controlled, validated, and compliant systems.

The role requires deep regulatory knowledge, experience with electronic records, and strong technical writing, communication, and project-management skills in a global, matrix environment.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years in Software Quality Assurance, Computer Software Assurance, or related fields in regulated environments.
• Experience applying risk-based software assurance concepts to production/QA processes.
• Familiarity with electronic records/e-signatures requirements (Part 11) and ISO 13485/JIS standards.

Responsibilities

• Lead risk-based CSAs and validation activities for medical device software.
• Oversee configuration, data migration, and validation across systems.
• Collaborate with IT, business owners, and suppliers to ensure compliance and traceability.
• Provide quality oversight for software validation plans, evidence, and reports.
• Coordinate efforts across sites and partners to maintain validated state.

Skills

Software QA

Regulatory

Education

Bachelor's degree in Engineering

Tools

eQMS

Job description

Lubrizol Corporation is seeking a Senior Corporate Software Quality Engineer to lead risk-based software assurance and computer system validation for medical device contract manufacturing operations. You will partner with Quality, IT, and sites to ensure fully controlled, validated, and compliant systems.

The role requires deep regulatory knowledge, experience with electronic records, and strong technical writing, communication, and project-management skills in a global, matrix environment.