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