CAPA and NC Manager (100%) - Basel

About the role

Medartis is strengthening its Quality team at its headquarters in Basel and is looking for an experienced, analytical CAPA and NC Manager working 100%. The role owns the Nonconformance and CAPA process and works cross-functionally with Quality, Manufacturing, Engineering, Regulatory Affairs and Supply Chain to drive compliance, product quality, patient safety and continuous improvement.

Key responsibilities

• Own and maintain the NC-CAPA process and associated procedures, and ensure compliance with requirements for control of nonconforming products
• Lead and facilitate investigations, root cause analysis and the definition of corrective and preventive actions
• Train and coach a network of NC-CAPA Owners across the organization
• Lead cross-functional teams to resolve complex quality issues and ensure investigations are evidence-based, timely and well documented
• Verify the effectiveness of actions before CAPA closure and present the process and records during external audits
• Ensure CAPAs are completed on time and meet regulatory and internal requirements
• Analyze quality events and CAPA metrics to define strategies to eliminate Field Safety Corrective Actions
• Prepare quality metrics and reports for management review and promote a culture of quality and continuous improvement

Required profile

• Master's or Bachelor's degree in Engineering, Life Sciences, Quality Management or a related technical discipline
• At least 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industry
• At least 3 years of experience managing CAPA and/or Nonconformance processes
• Experience supporting regulatory inspections and external audits preferred
• Fluent German and English, written and spoken

Required skills

• Strong knowledge of ISO 13485:2016 requirements
• Understanding of CAPA, Nonconformance Management, Complaint Handling, Supplier Quality and Risk Management
• Root cause analysis and problem-solving methods
• Electronic quality management systems (eQMS) and quality metrics analysis