In the context of an increase in activity, one of our clients, an international company specialized in the dynamic field of Aesthetic medicine, is looking for a Quality Assurance & Post Market Surveillance Specialist for its Swiss office based in the canton of Geneva. This company is growing significantly and is developing several activities in a standardized environment. The company is fully committed to the development of its employees and supports the innovative ideas of its teams.
As a Quality Assurance & Post Market Surveillance specialist, you will report directly to the Head of Regulatory Affairs. Your role will be to implement the quality assurance system, setting up the QMS in compliance with ISO 13485, European (MDR) and FDA requirements, coordinate post market surveillance activities and manage the product customer complaint management activities
Your main responsibilities:
- Setting up the quality assurance policies and procedures, and document quality assurance activities
- Being a support to the activities and projects of the quality management system as a quality referent for change control, non-conformities and CAPAs
- Ensure that standards and regulations are observed
- As a quality expert, participate in all audits (Health authority and notified body audits, internal audit and external audit)
- Being responsible for investigating customer complaints, making initial decisions on reports, providing failure analysis letters, and ensuring the completeness and consistency of complaints and related documentation
- Preparation of PMS plan and report, ensure timely analysis of the data
- Develop metrics to monitor trends
To lead this mission, we are looking for a profile with:
- Master’s degree in engineering, biology, biotechnology, or similar field
- Minimum 3+ years of experience in medical device field, with a previous experience in quality assurance
- Knowledge and understanding of regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDR requirements, etc.)
- Knowledge and understanding of GMP/ISO requirements, as well as MDR requirements for Post market Surveillance activities
- Excellent data collection and analysis skills
- Strong attention to details and excellent communication skills
- Fluent in English (spoken and written); French, Italian and Polish an asset
Do you recognize yourself trough this description? Send us your CV and let have a chat together!
You will love the international atmosphere and the career plan they offer!
Boost you career by joining this amazing company!