Location: Can be based in the main EU location after an initial 2 years in Finland
Our Client is advancing healthcare with innovative products combining the know-how in natural materials with research results in regenerative medicine. We are the first company to manufacture plant nanocellulose in ISO 13485 quality and are protected with more than 400 patents.
The role holder will play a key role in securing product quality and regulatory compliance and also have the possibility to participate in new business development.
The Quality Manager will share the vision for the products and is responsible for its high-quality execution, strategy implementation, and roadmap development. Critical will be maintaining and developing the ISO 13485 quality management system (QMS) in accordance with applicable regulations. The role holder will also manage and develop QMS processes such as annual planning, non-conformities (NC) treatment, CAPA, change control and supplier management. In addition, the role manages the process of legislation and standards monitoring and maintains and develops the QMS database. The role holder will support and steer the team members in daily quality operations such as quality control, document management, NC and CAPA processes, design and development.
A science background is required together with some experience in a leadership role within quality management systems and ideally regulatory affairs with focus to medical devices, ideally biomaterials rather than diagnostics or software. A deep understanding and working knowledge of ISO 13485, QC, GMP, MDR and FDA practices and document management is essential and your documentation practices are exact and persistent. Ideally, previous experience of medical device or in vitro medical device product development for the Clinical market and prior experience in the management of clinical trials is an advantage.