Director, Quality Assurance – Medical Device Services (Multi-Site)

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox Director, Quality Assurance – Medical Device Services (Multi-Site)Full-timeCompany DescriptionReporting directly to the President, Medical Device Services, the Senior Director, Quality & Laboratory Excellence is a strategic leadership role responsible for defining and executing the Quality vision across Eurofins Medical Device Services in North America.This position is far more than a traditional Quality Assurance leadership role. We are seeking an executive leader who can build a modern, scalable, risk-based Quality organization that enables rapid business growth while maintaining the highest standards of scientific integrity, laboratory excellence, regulatory compliance, and customer confidence.The successful candidate will lead the transformation and harmonization of Quality Management Systems across a growing network of laboratories and consulting businesses while supporting acquisitions, new service offerings, laboratory expansions, and future growth into medical device product development and engineering services.Working closely with the President the leadership team, this individual will position Quality as a strategic competitive advantage that enables innovation, operational excellence, and commercial success.In addition to leading Quality for Medical Device Services, the Senior Director will serve as an active member of the North America Quality Leadership Team, collaborating with Quality leaders across the BioPharma Product Testing (BPT) and Medical Device Services (MDS) businesses to advance enterprise-wide Quality initiatives, share best practices, harmonize Quality systems where appropriate, and strengthen a consistent culture of Quality across laboratories and business segments while recognizing the unique regulatory requirements of each market.Job DescriptionQuality Leadership & GovernanceProvide strategic leadership for Quality Assurance activities across multiple Medical Device Services sites.Develop, implement, and maintain a harmonized Quality Management System (QMS) aligned with corporate and regulatory requirements.Establish quality objectives, key performance indicators (KPIs), and continuous improvement initiatives across all sites.Foster a culture of quality, compliance, accountability, and customer focus.Lead Management Review processes and communicate quality performance metrics to executive leadership.Ensure effective escalation and resolution of significant quality and compliance issues.  Regulatory & Quality ComplianceEnsure compliance with applicable regulatory, accreditation, and quality standards, including:ISO/IEC 17025OECD Good Laboratory Practice (GLP) and FDA 21 CFR Part 58FDA 21 CFR Part 11FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820, as applicableISO 13485, as applicableMedical Device Single Audit Program (MDSAP), where applicableEuropean Union Medical Device Regulation (EU MDR), where applicableOther applicable national and international regulatory and accreditation requirementsLead Quality Systems supporting ISO/IEC 17025-accredited laboratories and GLP-compliant operations while ensuring appropriate application of QMSR and ISO 13485 requirements where applicable. Monitor changes in regulatory, accreditation, and industry standards and ensure timely implementation across all Medical Device Services sites. Serve as the executive Quality representative during regulatory inspections, accreditation assessments, customer audits, and corporate Quality reviews. Ensure timely and sustainable resolution of compliance observations, audit findings, and regulatory commitments through effective corrective and preventive action.Quality Systems OversightProvide oversight and approval for Quality Systems elements such as:Deviations and quality eventsCAPA investigationsChange controlsRisk assessmentsInternal auditsSupplier qualification and monitoring programsTraining and qualification systemsDocument...