CAPA & Nonconformance Quality Leader

Medartis; Basel; Hybrid; CHF 120,000 - 180,000; Full time

Job summary

Medartis, headquartered in Basel, Switzerland, is seeking an experienced CAPA and NC Manager to own the NC-CAPA process and drive cross-functional quality initiatives. You will lead investigations, define corrective actions, and mentor a network of CAPA owners to ensure timely, regulatory-compliant resolutions.

Ideal candidates hold a technical degree and 5–7 years in medical device QA, with strong ISO 13485 knowledge and fluency in German and English.

Qualifications

• Master's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or related technical discipline.
• 5–7 years in Quality Assurance or Quality Systems in medical devices.
• At least 3 years managing CAPA and Nonconformance processes.
• Experience supporting regulatory inspections and external audits.
• Strong ISO 13485:2016 knowledge and CAPA/Nonconformance processes.
• Fluent German and English; excellent analytical and cross-functional collaboration skills.

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.

Skills

CAPA Management

Nonconformance

Root Cause Analysis

eQMS

Quality Metrics

ISO 13485

Problem Solving

Cross-functional Collaboration

German & English Proficiency

Education

Master's or Bachelor's degree in Engineering/Life Sciences/Quality Management

Job description

Medartis, headquartered in Basel, Switzerland, is seeking an experienced CAPA and NC Manager to own the NC-CAPA process and drive cross-functional quality initiatives. You will lead investigations, define corrective actions, and mentor a network of CAPA owners to ensure timely, regulatory-compliant resolutions.

Ideal candidates hold a technical degree and 5–7 years in medical device QA, with strong ISO 13485 knowledge and fluency in German and English.