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Senior Corporate Quality Engineer
Job in
Brecksville, Cuyahoga County, Ohio, 44141, USA
Listed on 2026-10-01
Listing for:
Lubrizol
Full Time
position Listed on 2026-10-01
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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, OHHow You’ll Make an Impact 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 escalate 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 Device manufacturing sites.
Coach and mentor site Quality…
Position Requirements
10+ Years
work experience
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