CAPA and NC Manager 100%

pThe position serves as the process owner for Nonconformance and CAPA Management and works cross-functionally with Quality, Manufacturing, Engineering, Regulatory Affairs, Supply Chain, to drive compliance, product quality, patient safety, and continuous improvement. To strengthen our Quality team at our headquarters in Basel, we are looking for an experienced and analytical professional as /ph3CAPA and NC Manager 100% /h3h3Your responsibilities /h3ulliOwn and maintain the NC-CAPA process and associated procedures /liliEnsure compliance with requirements for control of nonconforming products /liliLead and facilitate investigations, root cause analysis, and definition of the associated corrective and preventive actions /liliTrain and coach a network of NC-CAPA Owners throughout the organization /liliLead cross-functional teams to resolve complex quality issues /liliEnsure investigations are evidence-based, timely, and adequately documented /liliDrive sustainable corrective actions that address true root causes /liliVerify effectiveness of implemented actions prior to CAPA closure /liliPresent the NC-CAPA process and records during external audits /liliEnsure CAPAs are completed within established timelines and meet regulatory and internal requirements /liliPrepare quality metrics and reports for management review /liliAnalyze quality events and CAPA Metrics to define the appropriate strategies to eliminate Field Safety Corrective Actions /liliPromote a culture of quality, compliance, and continuous improvement /liliMaster's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related technical discipline /liliMinimum 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industry /liliMinimum 3 years of experience managing CAPA and/or Nonconformance processes /liliExperience supporting regulatory inspections and external audits preferred /liliStrong knowledge of ISO 13485:2016 requirements /liliUnderstanding of CAPA, Nonconformance Management, Complaint Handling, Supplier Quality, and Risk Management processes /liliExperience with root cause analysis and problem-solving methodologies /liliProficiency in electronic quality management systems (eQMS) and quality metrics analysis /liliFluent in German and English, written and spoken /liliResults-oriented with strong cross-functional collaboration skills /liliExcellent analytical and problem-solving abilities /liliAbility to manage multiple priorities in a regulated environment /li /ulh3What we offer /h3pThis is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. /ph3About Medartis /h3pAt Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world’s leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide. /ppFor further information please visit our Website . /p #J-18808-Ljbffr