Our client is a medical device company focused on the development of innovative therapeutic solutions for the treatment of headache disorders.
They are developing a novel simple solution, discreet, a user-friendly device for a better health, comfort, and quality of life of patients. They strongly believe that people suffering from headaches should benefit from the latest neuromodulation therapies, which are safe alternatives to drugs.
Are you interested in helping to shape a young, innovative company? Would you like to participate in the development of active implants for the treatment of headaches? Then become part of a team consisting of young dynamic engineers, experienced scientists and successful start-up founders. Work in one of the fastest growing market segments of medical technology and benefit from our innovative solutions.
As Quality Manager, you will be responsible to coordinate and monitor activities which are required to meet the quality standards set forth by the ISO 13485 and ISO 14971 standards.
As Quality Manager, you will write or improve the policy and standards of the company. You will further advise on the improvement of the Quality Management System (eQMS) and report on the performance following the audit results you produced.
To get everybody pointing in the same direction, you will closely align the management to ensure the QMS is functioning properly and followed by employees, staff and sub-contractors. When appropriate, you will advise on changes and monitor the implementation thereof.
- Development and maintenance of a quality management system for class III medical devices by phases in order to support the effective activities in place.
- Assessment of complex medical devices for approvals.
- Management and planification of internal, external and notified bodies audits.
- Management of the quality for suppliers, including quality contracts.
- Development of quality management of products from development to market launch in Europe and the USA.
- Collaboration in the preparation of technical files according to the regulatory requirements.
- Review and adaptation of development documents with regard to regulatory aspects.
- Participation and support to the clinical team for the development of clinical quality processes.
- Active contributions regarding the communication with suppliers, notified bodies and other competent authorities.
- Design, implementation, deployment, trainings and monitoring of the company’s Document Control (DC) procedure for eQMS.
- Active contributions in the design and the implementation of the Risk Management procedure.
- Preparation, organization and recording of Design Reviews
- Master or bachelor’s degree with minimum one-year professional experience or minimum 4 years of professional experience in quality management systems and approval of class III medical devices or a university degree in an engineering discipline (e.g. informatics, electrical engineering, mechanical engineering or medical technology) with at least 2 years of experience in the field of quality management systems and approval of class III medical devices
- Strong knowledge of quality management systems according to ISO 13485 and ISO 14971 for the European and US market
- Experience in executing internal and external audits
- Experience in establishing and implementing supplier agreements within a quality system
- Experience in high-risk devices with R&D start-ups
- Experience in transferring R&D into a quality system and conversion into the pure product
- Good knowledge of European regulations for the Medical Devices (MDR 2017/745), including safety and performance.
- Knowledge of Jira/Confluence is a plus.
Your attributes and skills:
- You are motivated, enjoy your work and you are willing to take on responsibilities
- You have the ability to think your way into complex problems
- You are willing to travel to project partners and suppliers for meetings and audits
- Your documentation and communication skills in English are very good (speaking, reading and writing)
- You are looking at quality as a key activity to support the team and the company to reach the goal
Our client offers a dynamic and ever evolving start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.
Our client offers a full-time open-ended contract and good salary package and flexible advantages.