CAPA & Nonconformance Manager - Quality & Compliance

Medartis; Basel; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Medartis in Basel is seeking an experienced CAPA and NC Manager to own and optimize the nonconformance and CAPA processes across Quality, Manufacturing, Engineering, Regulatory Affairs, and Supply Chain.

You will lead investigations, drive root cause analysis, coordinate cross-functional actions, and ensure timely CAPA closure while maintaining compliance with ISO 13485 and regulatory audits.

Qualifikationen

• Master's or Bachelor's in Engineering, Life Sciences, Quality Management.
• 5–7 years in Quality Assurance/Quality Systems in the medical device industry.
• Minimum 3 years managing CAPA and Nonconformance processes.
• Experience supporting regulatory inspections and external audits preferred.
• Strong knowledge of ISO 13485:2016 requirements.

Aufgaben

• Own and maintain the NC-CAPA process and procedures
• Ensure compliance with requirements for control of nonconforming products
• Lead investigations, root cause analysis, and define corrective/preventive actions
• Train and coach NC-CAPA Owners across the organization
• Lead cross-functional teams to resolve complex quality issues
• Ensure investigations are evidence-based, timely, and documented
• Drive sustainable corrective actions addressing true root causes
• Verify effectiveness of actions prior to CAPA closure
• Present NC-CAPA process and records during external audits
• Ensure CAPAs are completed within established timelines and meet regulatory/internal requirements
• Prepare quality metrics and reports for management review
• Analyze quality events and CAPA Metrics to define strategies to eliminate Field Safety Corrective Actions
• Promote a culture of quality, compliance, and continuous improvement

Kenntnisse

CAPA & NC mgmt

Root cause analysis

Cross-functional teamwork

Regulatory audits

Quality metrics

ISO 13485 knowledge

Germany/English bilingual

Problem solving

Ausbildung

Master's or Bachelor's in Engineering/ Life Sciences/ Quality Mgmt

Tools

eQMS

Jobbeschreibung

Medartis in Basel is seeking an experienced CAPA and NC Manager to own and optimize the nonconformance and CAPA processes across Quality, Manufacturing, Engineering, Regulatory Affairs, and Supply Chain.

You will lead investigations, drive root cause analysis, coordinate cross-functional actions, and ensure timely CAPA closure while maintaining compliance with ISO 13485 and regulatory audits.