CAPA and NC Manager 100%

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

The position serves as the process owner for Nonconformance and CAPA Management and works cross-functionally with Quality, Manufacturing, Engineering, Regulatory Affairs, Supply Chain, to drive compliance, product quality, patient safety, and continuous improvement.

To strengthen our Quality team at our headquarters in Basel, we are looking for an experienced and analytical professional as

CAPA and NC Manager 100%

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

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.

For further information please visit our Website www.medartis.com.

We look forward to receiving your complete online application.

Medartis

Human Resources

www.medartis.com