QMS Specialist

Select how often (in days) to receive an alert: Create AlertWould you like to contribute to improving the quality of life of people with hearing loss?At Oticon Medical, we develop, produce and market bone-anchored hearing systems. At our site ITSA Medical in Vallauris (Sophia Antipolis), in the south of France, we specialize in the production of active implantable class III implants and soon also worldwide distribution of the company’s full product portfolio.We are now seeking a QMS Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with global regulatory requirements. Reporting to the QA Manager, you will play a key role in implementing, improving and merging local and global quality processes across the organization.Main responsibilitiesSupport the maintenance and continuous improvement of the Global Quality Management System (QMS)Ensure compliance with applicable regulatory requirements (ISO 13485, MDSAP, MDR 2017/745)Review and update QMS procedures and documentationParticipate in internal and supplier auditsSupport external auditsAssist in CAPA management, change control, and non-conformity handlingContribute to training activities related to QMS for employeesPrepare quality reports and provide transparency on quality performanceCollaborate with cross-functional teams to ensure quality standards are metKey Working RelationshipsClose collaboration with Operations, Regulatory Affairs, and Product Care teamsInteraction with notified bodies and auditors during inspectionsProfileBachelor’s degree or higher in engineering, life sciences, or related fieldMinimum 3–5 years of experience in Quality Assurance or Regulatory Affairs, preferably within medical devices or pharmaceutical industryGood understanding of quality systems and regulatory standardsStructured, detail-oriented, and proactive approachStrong communication, leadership, teamwork skills, and solution-oriented mindset #J-18808-Ljbffr