CAPA and NC Manager

Job description

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 as CAPA and NC Manager Your responsibilities Own and maintain the NC-CAPA process and associated procedures Ensure compliance with requirements for control of nonconforming products Lead and facilitate investigations, root cause analysis, and definition of the associated corrective and preventive actions Train and coach a network of NC-CAPA Owners throughout the organization Lead cross-functional teams to resolve complex quality issues Ensure investigations are evidence-based, timely, and adequately documented Drive sustainable corrective actions that address true root causes Verify effectiveness of implemented actions prior to CAPA closure Present the NC-CAPA process and records during external audits Ensure CAPAs are completed within established timelines and meet regulatory and internal requirements Prepare quality metrics and reports for management review Analyze quality events and CAPA Metrics to define the appropriate strategies to eliminate Field Safety Corrective Actions Promote a culture of quality, compliance, and continuous improvement Your qualifications Master's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related technical discipline Minimum 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industry Minimum 3 years of experience managing CAPA and/or Nonconformance processes Experience supporting regulatory inspections and external audits preferred Strong knowledge of ISO 13485:2016 requirements Understanding of CAPA, Nonconformance Management, Complaint Handling, Supplier Quality, and Risk Management processes Experience with root cause analysis and problem-solving methodologies Proficiency in electronic quality management systems (eQMS) and quality metrics analysis Fluent in German and English, written and spoken Results-oriented with strong cross-functional collaboration skills Excellent analytical and problem-solving abilities Ability to manage multiple priorities in a regulated environment About Medartis Medartis is one of the leading manufacturers of medical devices for osteosynthesis in the field of craniomaxillofacial surgery as well as the extremities.Medartis is committed to providing surgeons and operating room personnel with innovative titanium implants, instruments and services that represent advances in bone fixation and thus patients‘ quality of life. We offer you a diverse and interesting role with high quality requirements within a growing international company with excellent social benefits. We look forward to receiving your complete online application. For further information please visit our website Medartis Human Resources T +41 61 633 34 34