CAPA & Nonconformance Lead — Quality & Compliance

solique ag; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

Medartis in Basel is seeking an experienced CAPA and NC Manager to own the NC-CAPA process and drive continuous improvement across Quality, Manufacturing, and Regulatory affairs. You will lead investigations, define root causes, and implement robust CAPA actions, ensuring timely closure and regulatory compliance.

You will train a network of NC-CAPA Owners, collaborate cross-functionally, and prepare management quality metrics.

Qualifications

• Master's or Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field.
• Minimum 5-7 years of experience in Quality Assurance or Quality Systems within the medical device industry.
• Experience managing CAPA and Nonconformance processes.
• Experience supporting regulatory inspections and external audits.
• Strong knowledge of ISO 13485:2016 requirements.
• Experience with root cause analysis and problem-solving methodologies.
• Fluent in German and English, written and spoken.

Responsibilities

• Own and maintain the NC-CAPA process and associated procedures.
• Lead investigations, root cause analysis, and define 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 addressing 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 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.

Skills

CAPA & NC management

Quality systems

Root cause analysis

eQMS proficiency

Cross-functional collaboration

Analytical problem solving

German & English fluency

Regulatory inspections experience

Project management

Education

Master's/Bachelor's in Engineering, Life Sciences, Quality Management

Tools

eQMS

Job description

Medartis in Basel is seeking an experienced CAPA and NC Manager to own the NC-CAPA process and drive continuous improvement across Quality, Manufacturing, and Regulatory affairs. You will lead investigations, define root causes, and implement robust CAPA actions, ensuring timely closure and regulatory compliance.

You will train a network of NC-CAPA Owners, collaborate cross-functionally, and prepare management quality metrics.