QA Specialist

As a Quality Assurance Specialist with a focus on CAPA (Corrective and Preventive Actions), you will be a key contributor to maintaining and improving our quality management system. This role goes beyond investigations-you will ensure that CAPA processes are integrated into our overall QA strategy, supporting compliance, risk mitigation, and continuous improvement initiatives across the organization.

You will work closely with cross-functional teams to identify systemic issues, implement robust solutions, and strengthen our culture of quality in line with ISO 13485, EU MDR, and FDA QSR requirements.

Key Responsibilities

• CAPA Management & Investigations

  • Lead and document CAPA investigations, ensuring timely and compliant execution.
  • Perform root cause analysis using tools such as 5 Whys, Fishbone diagrams, and FMEA.
  • Define and implement corrective and preventive actions, monitoring effectiveness and sustainability.

• Quality Assurance Activities

  • Support the development and maintenance of the Quality Management System (QMS).
  • Participate in internal audits, supplier audits, and regulatory inspections.
  • Review and approve quality-related documentation, including SOPs and work instructions.
  • Ensure compliance with ISO 13485, EU MDR, FDA 21 CFR Part 11, and Swissmedic requirements.

• Continuous Improvement

  • Analyze CAPA trends and provide recommendations for systemic improvements.
  • Collaborate with Manufacturing, R&D, and Regulatory teams to drive quality initiatives.
  • Contribute to training programs on CAPA and quality processes.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum 5 years of experience in Quality Assurance within the medical device industry.
• Proven experience managing CAPA investigations and root cause analysis.
• Strong knowledge of ISO 13485, EU MDR, and FDA QSR.
• Excellent communication skills in French and English
• Familiarity with risk management tools and audit processes.