Description
We are supporting a well-established and companyQuality and Compliance Sr. DirectorWe are supporting a well-established and company in the medical devices sector in the search for a Quality & Compliance sr. Director. This is a key leadership role within a highly manufacturing-driven environment, offering strong and exposure.Quality and Compliance Sr. DirectorWell-established and company in the medical devices French-speaking SwitzerlandDescriptionAs Quality & Compliance Sr. Director, you will lead the overall Quality function on site, ensuring full compliance with global standards while driving continuous improvement across the responsibilities will include:Leading and developing the Quality function (QA, QC, manufacturing quality support, and on-site activities)Ensuring compliance with applicable standards and including ISO , ISO , FDA QSR (21 CFR 820), and MDSAPActing as Person Responsible for Compliance (PRRC) under EU MDR Overseeing and continuously improving the Quality Management System (QMS)Driving key quality processes such as CAPA, change control, non-conformities, and process inspections and audits (FDA, Notified Bodies, internal and external audits)Partnering cross-functionally with 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, X decision-makingProfileProfileProven experience in a senior Quality leadership role within the medical devices industry and with sterile knowledge of ISO , FDA QSR (21 CFR 820), and experience leading inspections (FDA and Notified Bodies)Solid background in manufacturing environments, including process 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 assetJob OfferA competitive package aligned with the seniority of the support for moving to SwitzerlandAn benefits package including additional perks and advantagesA position with strong visibility and impact within an environmentWork from X according to the needs of this role jid77dcdc1aen jit0415aen jpiy26aen
