CAPA and NC Manager 100%

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

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
• 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

What we offer

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company.

About Medartis

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world’s leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

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