Senior Corporate Quality Engineer

• ✓Drive the harmonization and continual improvement of site-level Quality Management Systems within a unified corporate QMS framework.
• ✓Translate corporate quality policies and regulatory

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

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.

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

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 techni