Senior Corporate Quality Engineer

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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.

Full
-Time / On-Site

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

As a Senior Corporate Quality Engineer, you will be at the forefront of our quality excellence, helping design, deploy, and continually improve a harmonized Quality Management System across our Medical Device contract manufacturing operations. You will provide corporate-level quality systems expertise and partner with site Quality teams and cross-functional process owners to ensure that corporate and site-level systems meet applicable regulatory, industry, customer, and internal requirements :

• Drive the harmonization and continual improvement of site-level Quality Management Systems within a unified corporate QMS framework.
• Translate corporate quality policies and regulatory requirements into clear, standardized, and executable Standard Operating Procedures, Work Instructions, process maps, forms, and supporting tools.
• Serve as corporate process steward for assigned QMS elements, maintaining process documentation, monitoring performance, evaluating process effectiveness, and coordinating improvement activities across sites.
• Partner with site Quality teams and cross-functional process owners to conduct gap assessments, evaluate existing practices, define implementation requirements, and align local processes with corporate QMS requirements.
• Lead implementation planning, stakeholder engagement, training coordination, and effectiveness monitoring for new or revised corporate quality processes.
• Lead the development and optimization of harmonized quality processes, workflows, document structures, and business requirements implemented within the corporate electronic Quality Management System.
• Partner with digital quality, software quality, Information Technology, system owners, and site stakeholders to ensure that eQMS workflows accurately reflect approved business processes and applicable quality requirements.
• Plan, lead, and execute risk-based corporate internal audits, compliance assessments, and quality-system reviews across Medical Device manufacturing sites.
• Prepare clear and evidence-based audit reports that communicate compliance gaps, systemic risks, and opportunities for improvement to site and corporate leadership.
• Evaluate corrections, root-cause analyses, corrective-action plans, and effectiveness evidence associated with audit observations; monitor progress and elevate material compliance risks or overdue actions as appropriate.
• Analyze cross-site QMS data, audit results, process metrics, and quality trends to identify systemic risks, harmonization opportunities, and recommendations supporting management review and organizational objectives.
• Support the integration of risk-based thinking into corporate quality processes in accordance with ISO 14971 and applicable QMS requirements.
• Provide technical guidance on QMS integration, documentation architecture, process interactions, quality-system governance, and regulatory compliance.
• Support the integration of new facilities, acquisitions, or expanded operations into the corporate QMS framework, as assigned.
• Support regulatory, certification, customer, and other external audit-readiness activities, including targeted remediation and deployment support at Medical…