CAPA and NC Manager 100%

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

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.