Senior Corporate Quality Engineer
or drop it. Should not repeat job title as heading. So we need sections: maybe "About the role" (the introductory paragraph), "Responsibilities" (the "How You’ll Make An Impact" bullet list), "Requirements" (Required Qualifications), "Qualifications" maybe for Preferred? But spec says use headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections with real content. We have About the role (intro). Responsibilities (list). Requirements (Required Qualifications). Qualifications (Preferred Qualifications). Benefits (Benefits That Empower You). Possibly Skills? Could embed skills within requirements but we have no separate Skills section. Pay and Schedule not present, so omit. Also Work Environment maybe could be part of About the role or separate? Not in list headings; we could incorporate into About the role or maybe as a separate section not in allowed headings? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., implying those are examples but we should use those headings when appropriate. It doesn't forbid other headings, but better to stick to those. Work Environment could be part of About the role or maybe we could put under About the role. We'll include a short paragraph about work environment inside About the role or maybe as a separate
after About the role. We must preserve all substantive information. So we need to include the bullet points from responsibilities, required qualifications, preferred qualifications, benefits. We need to format lists with
- . For prose use
. We must not include boilerplate like EEO etc. The posting didn't have that. We need to output only HTML fragment. Let's craft:
About the role
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. Role 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.
But we need to avoid repeating job title; fine. Then Responsibilities:Responsibilities
- 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.
Requirements
- 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.
Qualifications
- 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.
- Advanced technical-writing experience involving complex quality-system procedures, corporate policies, audit reports, or compliance-remediation plans.
- 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.
Benefits
- 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
after benefits. However it's minor metadata; we could include as a
but not as heading. The instruction: preserve ALL substantive information; do not invent or summarize away detail. So we should include that line. It's not boilerplate; it's a link to benefits. We'll add a
after benefits:
Learn more at benefits.lubrizol.com.
But we must not add markdown; just HTML. Use . That's fine. We also have the closing paragraph about Lubrizol: Imagined for Life... That's boilerplate marketing; maybe considered substantive? It's about company description; could be considered part of About the role? Already we have some intro. The later paragraph about Lubrizol's history etc might be considered boilerplate but it's still substantive info about company. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This is not those; it's company description. Could keep as part of About the role or separate section? But we already have About the role with intro; we could append that paragraph to About the role as additional. However we must not repeat job title as heading; fine. We need to ensure we don't include duplicated lines. The posting had repeated lines? Not sure. Let's craft final HTML:
About the role
Shape the Future with Us. At