Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline.
5+ years of Quality Engineering or Quality Assurance experience in the medical-device industry or regulated life sciences.
Experience with ISO 13485:2016, ISO 14971, and FDA regulations (21 CFR Part 820).
Demonstrated ability to harmonize and standardize Quality Management Systems across multiple sites.
Strong technical writing and analytical skills, with proficiency in Microsoft Office applications.
Ability to lead cross-functional initiatives and influence stakeholders effectively.
Responsibilities
Drive the harmonization and improvement of Quality Management Systems across sites.
Translate corporate quality policies into standardized procedures and tools.
Serve as process steward for assigned QMS elements, monitoring performance and coordinating improvements.
Conduct gap assessments and align local processes with corporate QMS requirements.
Lead internal audits and compliance assessments across manufacturing sites.
Analyze QMS data and audit results to identify risks and opportunities for improvement.
Coach site Quality personnel on corporate quality processes and auditing principles.
Benefits
Competitive salary with performance-based bonuses.
401(k) match and Age-Weighted Defined Contribution plan.
Comprehensive medical, dental, and vision coverage.
Health Savings Account (HSA) options.
Paid holidays, vacation, and parental leave.
Flexible work environment.
Opportunities for learning and professional development.
Inclusive culture with community engagement initiatives.
Full Job Description
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 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 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, or an environment involving shared quality responsibilities between an OEM and a contract manufacturer.
Experience building, scaling, or integrating a corporate or multi-site Quality Management System.
Experience serving as process owner, process steward, or subject-matter expert for one or more major QMS processes, such as CAPA, internal audit, management review, document control, change control, supplier quality, complaint handling, training, validation, or risk management.
Experience supporting the implementation, migration, or continuous improvement of an enterprise eQMS.
Experience developing QMS metrics, management-review inputs, dashboards, Pareto analyses, or other cross-site quality analytics.
Experience supporting regulatory inspections, ISO 13485 certification audits, MDSAP audits, or medical-device customer audits.
Experience with quality agreements, customer-specific quality requirements, change-notification obligations, or OEM/CMO responsibility matrices.
ISO 13485 Lead Auditor training or certification.
ASQ certification, such as Certified Quality Engineer, Certified Quality Auditor, or Certified Manager of Quality/Organizational Excellence.
Experience with organizational change management, training deployment, or adoption of standardized processes across multiple sites.
Familiarity with statistical analysis, data visualization, or business-intelligence tools used to evaluate QMS performance.
Your Work Environment
At Lubrizol, we're committed to providing a safe, inclusive, and empowering environment where you can do your best work-whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include:
Vision correctable to 20/20.
Hearing correctable to unamplified human voice.
Manual dexterity: excellent
Ability to meet safety, regulatory, and health guidelines without assistance.
Continuous mental/visual concentration
Ability to travel by auto/air unassisted.
Benefits that Empower You
Competitive salary with performance-based bonus plans
401(k) match + Age-Weighted Defined Contribution
Comprehensive medical, dental & vision coverage
Health Savings Account (HSA)
Paid holidays, vacation, and parental leave
Flexible work environment
Learning and development opportunities
Career and professional growth
Inclusive culture and vibrant community engagement Learn more at benefits.lubrizol.com!
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About The Lubrizol Corporation
The Lubrizol Corporation is a provider of specialty chemicals for the transportation, industrial, and consumer markets. These products include additives for engine oils and other transportation-related fluids, additives for industrial lubricants, and additives for gasoline and diesel fuel. The company also produces specialty materials for the plastics, coatings, and pharmaceuticals markets. Lubrizol operates in more than 100 countries and has manufacturing facilities in 17 countries.
