Senior Corporate QMS Engineer – Medical Devices

Lubrizol Corporation; Brecksville (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive salary with bonus

401(k) match

Health Savings Account (HSA)

Paid holidays, vacation, and parental

Job summary

Lubrizol Corporation is seeking a Senior Corporate Quality Engineer to lead harmonization of the Quality Management System across Medical Device manufacturing sites. You will translate policy into standardized procedures, drive internal audits, and coordinate improvement activities with site quality teams.

The role emphasizes regulatory compliance, risk-based thinking, and collaboration across functional partners, with a focus on delivering compliant, high-quality medical-device processes.

Qualifications

• Bachelor’s degree in engineering or related field with strong quality focus.
• 5+ years of quality engineering or quality systems experience in regulated life-sciences.
• Experience implementing ISO 13485 and harmonizing QMS across sites.

Responsibilities

• Lead harmonization of QMS across sites within a unified corporate framework.
• Translate policies into SOPs, work instructions, and process maps.
• Plan, conduct, and report internal audits; drive corrective actions and risk mitigation.

Skills

Quality Engineering

Regulatory Compliance

Cross-functional Collaboration

Technical Writing

Process Improvement

Risk Management

Education

Bachelor’s degree in Engineering

ISO 13485 knowledge

FDA QMS (21 CFR 820) knowledge

Tools

Excel

Word

PowerPoint

SharePoint

Teams

Job description

Lubrizol Corporation is seeking a Senior Corporate Quality Engineer to lead harmonization of the Quality Management System across Medical Device manufacturing sites. You will translate policy into standardized procedures, drive internal audits, and coordinate improvement activities with site quality teams.

The role emphasizes regulatory compliance, risk-based thinking, and collaboration across functional partners, with a focus on delivering compliant, high-quality medical-device processes.