CAPA & NC Quality Lead — Drive Compliance

Medartis AG; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Medartis AG, headquartered in Basel, Switzerland, seeks an experienced CAPA and NC Manager to own the nonconformance and CAPA processes across Quality, Manufacturing, and Engineering. You will drive investigations, root-causes, and corrective actions to ensure patient safety and compliance.

You will train a network of NC-CAPA Owners and coordinate with regulatory affairs to meet internal and external audit requirements.

Qualifikationen

• Lead and own NC-CAPA process and procedures.
• Ensure compliance for control of nonconforming products.
• Lead investigations, root cause analysis, and actions.
• Train NC-CAPA Owners across the organization.
• Support regulatory inspections and external audits.

Aufgaben

• Own and maintain NC-CAPA process and procedures.
• Lead cross-functional teams to resolve complex quality issues.
• Verify effectiveness of implemented actions prior to CAPA closure.
• Present NC-CAPA process and records during external audits.
• Prepare quality metrics and reports for management review.
• Promote a culture of quality, compliance, and continuous improvement.

Kenntnisse

CAPA & NC mgmt

German & English

Cross-functional collaboration

Problem solving

eQMS

Ausbildung

Master's/Bachelor's in Engineering

Tools

eQMS

Jobbeschreibung

Medartis AG, headquartered in Basel, Switzerland, seeks an experienced CAPA and NC Manager to own the nonconformance and CAPA processes across Quality, Manufacturing, and Engineering. You will drive investigations, root-causes, and corrective actions to ensure patient safety and compliance.

You will train a network of NC-CAPA Owners and coordinate with regulatory affairs to meet internal and external audit requirements.