QA/RA Specialist

We are looking for an experienced and customer-oriented QA/RA Specialist to join our team!

In this role, you will help our customers bring meaningful medical devices to market by ensuring their products are safe, effective, and compliant with applicable standards and regulations. You will support and guide customers through the entire development lifecycle, producing and reviewing documentation, requirement definitions, and risk management materials. You will work as part of a friendly and highly skilled QA/RA team.

This is a permanent position located in Espoo or Kempele, with hybrid work possibilities.

Your main responsibilities:

• Participate in various projects to ensure our customers' medical device and IVD device compliance with applicable standards and regulations
• Support design and development of medical devices and IVD throughout the product lifecycle especially on SW development activities and documentation
• Plan, execute and report risk management activities
• Support documentation and risk assessment for medical devices, including cybersecurity and AI/ML
• Define product requirements together with the customer, establish design controls and traceability, ensure documented evidence for verification and regulatory requirements such as GSPR (general safety and performance requirements).
• Implement quality management systems and processes for customers and support continuous improvement by conducting internal audits
• Create regulatory roadmaps and support product qualification and classification

What we expect from you

• A relevant university degree, for example in biomedical engineering, medical technology or another technical or lifescience field
• Over 5 years of experience in the medical device or IVD industry or other regulated fields, including more than 3 years in QARA roles
• Solid knowledge of medical device development and relevant standards (ISO 13485, ISO 14971, IEC 62304) as well as familiarity with MDR, IVDR, and FDA requirements
• Experience in medical device or software driven device (MDSW) development, documentation practices, and design control, verification and validation processes
• Strong communication skills, customer-oriented approach, and an independent, systematic working style
• Excellent English skills, basic proficiency in Finnish, and strong technical writing abilities

Considered an advantage:

• Familiarity with AI applications, cybersecurity, and connectivity in the context of medical devices
• Experience with software development or Agile methods (e.g., Scrum), ALM tools such as Jira, and auditing.

What we offer

• Meaningful work alongside highly skilled experts in the field
• Support of a dedicated and welcoming team – you will never be left alone.
• Excellent employee benefits including comprehensive occupational healthcare and insurance coverage, lunch-, sports-, wellbeing-, and culture benefits
• Hybrid working opportunities and flexible working hours

Project assignment and role start

The exact starting project will be defined based on an upcoming customer assignment. Since our organization operates as a CDMO with a diverse project portfolio, your first responsibilities will be tailored according to the customer needs and the regulatory scope of the selected project. This means you will step into a role that matches your expertise from day one, while also having the opportunity to grow your responsibilities as the project evolves.