We are looking for a part-time Quality Manager
Medixine is A Finnish medical software provider, our product is a comprehensive cloud based remote patient monitoring software platform. We are looking for an experienced and hands-on Quality Manager to support the development and quality management of medical devices. In this role, you will work in a central position ensuring that our products meet the required quality and regulatory criteria throughout their entire lifecycle. The role suits someone who is comfortable with both operational work and managing broader entities.
Main responsibilities
- Develop and implement quality management system and processes
- Act as a PRRC and contact person to notified body and authorities
- Ensure medical device compliance with applicable standards and regulations
- Support software medical device development throughout the product lifecycle, with a particular focus on software development activities, change management, and technical documentation.
- Lead and support regulatory documentation, risk management, and compliance assessments for medical device software products
- Create regulatory roadmaps and support product qualification and classification
What we expect from you
- A relevant university degree
- Over 3 years of experience in the medical device industry
- Solid knowledge of medical device development and relevant standards (ISO 13485, ISO 14971, IEC 62304) as well as familiarity with MDR requirements
- Strong communication skills, customer-oriented approach, and an independent, systematic working style
We offer you the opportunity to directly influence the quality and safety of our products and to take part in developing our operations in a growing organization. The role is flexible and can be arranged as part-time work, with the possibility to shape the job content based on your expertise.
Interested? Please send your application, CV, and salary expectation as soon as possible to rekry@medixine.com. The position will be filled as soon as a suitable candidate is found.