Senior Corporate Quality Engineer

Lubrizol Corporation; Brecksville, Northern (OH, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

The role requires ISO 13485, ISO 14971, and FDA QMS experience, strong technical writing and project management, and willingness to travel to manufacturing locations. This on-site position in Ohio offers opportunities to shape corporate quality processes and governance.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline.
• 5+ years of progressively responsible Quality Engineering, Quality Systems, or Quality Assurance experience in the medical-device industry or another highly regulated life-sciences manufacturing environment.
• Experience developing, implementing, maintaining, or improving Quality Management System processes in accordance with ISO 13485.
• Experience with ISO 13485:2016, ISO 14971, and the U.S. FDA Quality Management System Regulation, 21 CFR Part 820.
• Demonstrated experience with QMS harmonization, process standardization, or the integration of quality systems across multiple facilities, business units, or acquired organizations.
• Experience translating regulatory requirements or corporate policies into controlled procedures, work instructions, process maps, forms, and implementation tools.
• Experience conducting internal quality-system audits and evaluating corrective actions, root-cause analyses, and effectiveness evidence.
• Experience defining business processes, workflows, requirements, or documentation structures for an electronic Quality Management System.
• Demonstrated ability to lead complex cross-functional initiatives and influence stakeholders without direct reporting authority.
• Strong technical writing, analytical, problem-solving, project-management, and verbal communication skills.
• Ability to analyze quality-system data and communicate risks, trends, and recommendations to both technical and leadership audiences.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, and SharePoint.
• Ability and willingness to travel to company manufacturing locations as required.

Responsibilities

• Drive harmonization and continual improvement of site-level Quality Management Systems within a unified corporate QMS framework.
• Translate corporate quality policies and regulatory requirements into standardized SOPs, work instructions, process maps, forms, and supporting tools.
• Serve as corporate process steward for assigned QMS elements, maintaining documentation and coordinating improvements across sites.
• Lead implementation planning, stakeholder engagement, training coordination, and effectiveness monitoring for new or revised corporate quality processes.
• Develop and optimize harmonized quality processes, workflows, document structures, and electronic QMS requirements.
• Partner with IT and site stakeholders to ensure eQMS workflows reflect approved processes and quality requirements.
• Plan, lead, and execute risk-based internal audits, compliance assessments, and quality-system reviews across Medical Device sites.
• Prepare audit reports communicating gaps, risks, and improvement opportunities to leadership.
• Evaluate corrections, root-cause analyses, and corrective actions; monitor progress and escalate risks as needed.
• Analyze cross-site QMS data and trends to identify risks and harmonization opportunities.

Skills

Technical writing

Analytical thinking

Problem-solving

Project management

Verbal communication

Education

Bachelor’s degree in Engineering, Life Sciences, CS, Quality, or related

Tools

Microsoft Office

Excel

Word

PowerPoint

Teams

SharePoint

Job description

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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 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 Device manufacturing sites.
• Coach and mentor site Quality personnel and cross-functional stakeholders on corporate quality processes, auditing principles, root-cause analysis, risk-based decision-making, and effective QMS implementation.
• Maintain awareness of evolving medical-device quality-system regulations, standards, and industry practices and assess their potential impact on corporate and site-level processes.
• Observe and promote Company standards and policies related to safety, quality, ethics, and productivity.

Required Qualifications that Enable Your Success

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline.
• 5+ years of progressively responsible Quality Engineering, Quality Systems, or Quality Assurance experience in the medical-device industry or another highly regulated life-sciences manufacturing environment.
• Demonstrated experience developing, implementing, maintaining, or improving Quality Management System processes in accordance with ISO 13485.
• Experience with ISO 13485:2016, ISO 14971, and the U.S. FDA Quality Management System Regulation, 21 CFR Part 820.
• Demonstrated experience with QMS harmonization, process standardization, or the integration of quality systems across multiple facilities, business units, or acquired organizations.
• Experience translating regulatory requirements or corporate policies into controlled procedures, work instructions, process maps, forms, and implementation tools.
• Experience conducting internal quality-system audits and evaluating corrective actions, root-cause analyses, and effectiveness evidence.
• Experience defining business processes, workflows, requirements, or documentation structures for an electronic Quality Management System.
• Demonstrated ability to lead complex cross-functional initiatives and influence stakeholders without direct reporting authority.
• Strong technical writing, analytical, problem-solving, project-management, and verbal communication skills.
• Ability to analyze quality-system data and communicate risks, trends, and recommendations to both technical and leadership audiences.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, and SharePoint.
• Ability and willingness to travel to company manufacturing locations as required.

Preferred Qualifications That Drive You Forward

• Experience in medical-device contract manufacturing, outsourced manufacturing, supplier quality