Sauvegarder Retour à la recherche Description du poste Résumé Offres similaires Added 09/04/2026Key leadership role offering strong strategic and operational exposureWell-established and innovative company in the medical devices sectorÀ propos de notre clientWell-established and innovative international company in the medical devices sector. Location: French-speaking SwitzerlandDescription du posteAs Quality & Compliance Sr. Director, you will lead the overall Quality function on site, ensuring full compliance with global regulatory standards while driving continuous improvement across the organization.Your responsibilities will include:Leading and developing the Quality function (QA, QC, manufacturing quality support, validation, and on-site regulatory activities)Ensuring compliance with applicable standards and regulations, including ISO 13485, ISO 9001, FDA QSR (21 CFR 820), and MDSAPActing as Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745Overseeing and continuously improving the Quality Management System (QMS)Driving key quality processes such as CAPA, change control, non-conformities, and process validationLeading regulatory inspections and audits (FDA, Notified Bodies, internal and external audits)Partnering cross-functionally with Operations, R&D, Clinical, and other stakeholdersMonitoring quality performance, identifying trends, and implementing robust corrective actionsPromoting a strong culture of quality, compliance, and continuous improvementActing as a key member of the site leadership team, contributing to strategic decision-makingProfil recherchéProfileProven experience in a senior Quality leadership role within the medical devices industry and with sterile products.Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and international regulatory frameworksDemonstrated experience leading regulatory inspections (FDA and Notified Bodies)Solid background in manufacturing environments, including process validation and quality controlGood understanding of EU MDR and ability to take on PRRC responsibilitiesStrong leadership and stakeholder management skillsAnalytical mindset with a hands-on approach to problem-solvingLanguagesFluent English is requiredFrench highly desired and/or German would be an additional assetInformations complémentairesA competitive compensation package aligned with the seniority of the roleRelocation support for candidates moving to SwitzerlandAn attractive benefits package including additional perks and advantagesA strategic position with strong visibility and impact within an international environmentWork from home available according to the needs of this roleIndiquer la référence de l'offreJN-032026-6982590Résumé du posteSecteurIngénierie & ProductionSpécialisation QualitéIndustrieHealthcare / PharmaceuticalLocalisationSuisseType de contratPermanentRéférence de l´offreJN-032026-6982590
