The 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 asCAPA and NC Manager 100%Your responsibilitiesOwn and maintain the NC-CAPA process and associated proceduresEnsure compliance with requirements for control of nonconforming productsLead and facilitate investigations, root cause analysis, and definition of the associated corrective and preventive actionsTrain and coach a network of NC-CAPA Owners throughout the organizationLead cross-functional teams to resolve complex quality issuesEnsure investigations are evidence-based, timely, and adequately documentedDrive sustainable corrective actions that address true root causesVerify effectiveness of implemented actions prior to CAPA closurePresent the NC-CAPA process and records during external auditsEnsure CAPAs are completed within established timelines and meet regulatory and internal requirementsPrepare quality metrics and reports for management reviewAnalyze quality events and CAPA Metrics to define the appropriate strategies to eliminate Field Safety Corrective ActionsPromote a culture of quality, compliance, and continuous improvementMaster's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related technical disciplineMinimum 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industryMinimum 3 years of experience managing CAPA and/or Nonconformance processesExperience supporting regulatory inspections and external audits preferredStrong knowledge of ISO 13485:2016 requirementsUnderstanding of CAPA, Nonconformance Management, Complaint Handling, Supplier Quality, and Risk Management processesExperience with root cause analysis and problem-solving methodologiesProficiency in electronic quality management systems (eQMS) and quality metrics analysisFluent in German and English, written and spokenResults-oriented with strong cross-functional collaboration skillsExcellent analytical and problem-solving abilitiesAbility to manage multiple priorities in a regulated environmentWhat we offerThis is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company.About MedartisAt 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.For further information please visit our Website . #J-18808-Ljbffr
CAPA and NC Manager 100% in Basel Arbeitgeber: solique ag
Die Psychiatrische Universitätsklinik Zürich bietet eine herausragende Arbeitsumgebung für Psychologen/innen, die sich für die Kinder- und Jugendpsychiatrie engagieren. Mit einem starken Fokus auf interdisziplinäre Zusammenarbeit und kontinuierliche Weiterbildungsmöglichkeiten fördert die PUK eine positive und unterstützende Unternehmenskultur. Zudem profitieren Mitarbeiter von flexiblen Arbeitszeiten und der Möglichkeit, in einem innovativen und dynamischen Umfeld zu arbeiten, das sich der Verbesserung der psychischen Gesundheit von Kindern und Jugendlichen widmet.
