CAPA & NC Manager: Quality & Continuous Improvement Lead

Medartis; Basel; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Medartis, headquartered in Basel, Switzerland, seeks an experienced CAPA and NC Manager to own the NC-CAPA process and drive cross-functional improvements across Quality, Manufacturing, Engineering, Regulatory Affairs and Supply Chain.

You will lead investigations, root cause analysis, and corrective actions, train a network of NC-CAPA owners, and ensure timely, well-documented CAPAs with external audits. Fluent German and English are required.

Qualifikationen

• Master's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field.
• Minimum 5–7 years of experience in Quality Assurance/Quality Systems in medical devices.
• Minimum 3 years of experience managing CAPA and Nonconformance processes.
• Experience with regulatory inspections and external audits preferred.
• Strong knowledge of ISO 13485:2016.

Aufgaben

• Own and maintain the NC-CAPA process and procedures.
• Ensure compliance for control of nonconforming products.
• Lead investigations, root cause analysis, and corrective 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 well documented.
• Drive sustainable CAPAs addressing true root causes.
• Verify effectiveness of actions prior to CAPA closure.
• Present NC-CAPA process and records during external audits.
• Prepare quality metrics and reports for management review.
• Analyze quality events and CAPA metrics to improve safety and quality.

Kenntnisse

Quality Management

CAPA

Nonconformance Management

Root Cause Analysis

Cross-functional Collaboration

Data Analysis

eQMS

Regulatory Inspections

Problem-solving

Quality Metrics

Ausbildung

Bachelor's or Master's in Engineering, Life Sciences, Quality Management

Tools

eQMS

Jobbeschreibung

Medartis, headquartered in Basel, Switzerland, seeks an experienced CAPA and NC Manager to own the NC-CAPA process and drive cross-functional improvements across Quality, Manufacturing, Engineering, Regulatory Affairs and Supply Chain.

You will lead investigations, root cause analysis, and corrective actions, train a network of NC-CAPA owners, and ensure timely, well-documented CAPAs with external audits. Fluent German and English are required.