Quality Manager / Engineer
AVVie is an exciting early-stage medical device company with innovative, minimally invasive technology for the treatment of mitral valve disease.
Roll & Responsibilities
The candidate will provide guidance and support on quality requirements to AVVie during the design, prototype, and development phases of a Mitral Butterfly Implant.
Main responsibility is to implement and maintain a QMS and support the R&D team with all quality-related issues.
- Implement and maintain quality management system (ISO 13485 & US FDA QSR) in cooperation with external consultant
- Compiling of documentation and integration into internal QM system
- Actively stays current with external and internal quality system standards and requirements (ISO 13485, ISO 14971, and other applicable standards)
- Develop, implement and maintain the company’s risk management processes
- Ensuring compliance to design control procedures
- Preparation and monitoring of trainings
- Assists in coordination and management of all internal, supplier and external audits
- Providing support in identifying deficiencies in quality systems, defining and implementing systematic improvements
- Drive project activities to ensure timely completion of quality-related project milestones
- Degree in Mechanical Engineering, Biomedical Engineering, or related disciplines
- Minimum of 3 years of related experience (Quality Systems Engineer) within the medical device industry (Class III medical devices)
- Prior experience in setting up a QMS in the medical device environment
- Deep practical knowledge of ISO 13485 and ISO 14971 requirements
- Experience with ISO 10555 is a plus
- Experience in a production environment is a plus
- Interested in supporting the development of an innovative structural heart concept
- Start-up mentality
- A good team player who can time-manage and work independently in a fast-paced and challenging environment
- Strong organizational and analytical skillsFluency in English is mandatory