Senior Corporate Quality Engineer

Senior Corporate Quality Engineer

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.

• 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.

• Your Work Environment

• At Lubri