Opslaan Terug naar zoeken Functie Samenvatting Soortgelijke jobs Toegevoegd 16/10/2026Lead Quality Assurance across a complex European distribution networkDrive compliance, operational excellence and continuous improvement in MedTechOver onze klantOur client is a global healthcare manufacturer with a long-standing reputation for innovation, patient focus and regulatory excellence. With products distributed across more than 90 countries, quality is at the heart of every operational decision. The European Distribution Centre serves as a critical hub within the organisation's global supply chain and plays a vital role in ensuring product availability, regulatory compliance and customer satisfaction throughout Europe.FunctieAs a member of both the Global Quality Leadership Team and the European Distribution Centre Leadership Team, you will provide strategic and operational leadership for all Quality Assurance activities related to European distribution operations. You will champion a proactive culture of quality while ensuring the organisation remains inspection-ready and compliant with evolving regulatory requirements.Lead, develop and mentor a team of Quality Assurance professionals, establishing clear objectives, succession planning and professional development programmesOwn the Quality Management System for the European Distribution Centre and provide quality oversight of external logistics partners, including 3PL and 4PL providers across EuropeDefine and execute the quality strategy for European distribution activities, ensuring alignment with global quality objectives and business prioritiesEnsure ongoing compliance with ISO 13485, ISO 14971, MDR, MDD, applicable FDA requirements and Good Distribution Practices (GDP)Act as the quality representative during Notified Body, regulatory authority and customer audits, driving successful inspection outcomes and timely remediation of findingsProvide quality oversight of change control, CAPA management, non-conformance investigations, complaint handling, risk management and internal audit programmesMaintain oversight of finished goods release activities and support quality decision-making related to product disposition where applicableAssess and approve quality requirements associated with product transfers, product lifecycle changes and the introduction of new products into the European marketDrive root cause investigations and continuous improvement initiatives, leveraging data analysis, quality metrics and risk-based decision-makingPartner with Supply Chain, Operations, Regulatory Affairs and Commercial teams to ensure robust quality processes throughout the distribution networkManage departmental budgets, resource planning and quality performance indicators to support operational and strategic objectivesProfielYou are an experienced Quality leader who combines deep regulatory expertise with strong people leadership skills. You have successfully managed Quality Systems within highly regulated medical device or pharmaceutical environments and are comfortable operating in a matrix organisation with significant stakeholder exposure.You bring a proactive approach to compliance, a passion for continuous improvement and the credibility to influence both operational and executive-level decision-making.Bachelor's or Master's degree in Quality, Life Sciences, Engineering, Supply Chain, Pharmacy or a related scientific disciplineMinimum 8 years of experience within Medical Devices, Pharmaceuticals or another highly regulated healthcare environmentMinimum 5 years of leadership experience with direct responsibility for Quality teams and Quality SystemsProven expertise in ISO 13485, ISO 14971, MDR, MDD and quality system regulations governing medical device distributionDemonstrated experience leading external audits and serving as primary contact for regulatory authorities and Notified BodiesStrong knowledge of GDP, supplier quality management and distribution quality oversightExperience managing CAPA systems, risk management processes and complex compliance investigationsTrack record of successfully implementing quality improvements and driving operational excellence initiativesStrong analytical skills with the ability to interpret quality trends, performance metrics and compliance dataExcellent stakeholder management and communication skills, with the ability to influence across all organisational levelsFluent English language skills, both written and verbalAanbodCompetitive base salary aligned with senior Quality leadership positions within the Medical Device industryAnnual performance bonus and comprehensive benefits packageSignificant visibility within global Quality and Supply Chain leadership teamsOpportunity to influence quality strategy across multiple European marketsDirect participation in international leadership forums and global quality initiativesExposure to regulatory inspections, strategic business projects and organisational transformation programmesClear opportunities for long-term career progression within a global healthcare organisationSEO Keywords: Quality Assurance Manager Europe, Medical Device Quality Manager, Distribution Quality Assurance Manager, ISO 13485, MDR Compliance, GDP Medical Devices, Quality Systems Manager, Regulatory Compliance, MedTech Careers, Roosendaal Quality Jobs, European Distribution Centre, Quality Leadership Medical Devices.ContactLard HermsenReferentienummerJN-102026-7127770Vacature samenvattingSectorHealthcare & Life SciencesSub SectorQuality & Regulatory AffairsIndustrieHealthcare / Pharmaceutical Vacatures per locatieNoord-BrabantContract TypePermanentConsultantLard HermsenVacature referentieJN-102026-7127770
