Innokas is a growing technology company specializing in healthcare technology. We produce healthcare technology design projects and products both for leading international companies and domestic growth companies. Together with our customers, we transform their ideas into high-quality end-products. We offer reliable concept elaboration, agile design & development, cost-efficient contract manufacturing, and professional quality & regulatory services to meet our customers’ outsourcing needs. Innokas is part of the Finnish family-owned Paree Group with over 450 employees and about 70M€ revenue. We have offices in Finland in the Oulu region and capital area and in Estonia in Tallinn. For more information, visit our website at www.innokasmedical.fi
We are looking for an experienced and customer-oriented QA/RA Specialist to join Innokas!
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.
In your daily work, you will guide customers throughout the medical device development process. You will either support or produce documentation, requirement definitions, and risk management materials. In addition, you will support our internal quality team as well as other teams, for example, in internal audits.
You will be part of a friendly QA/RA team of highly skilled professionals.
This is a permanent position based in Espoo or Kempele.
Your main responsibilities:
- Ensure compliance with applicable standards and regulations
- Support design and development of medical devices throughout the product lifecycle especially on SW development activities and documentation
- Plan, execute and report risk management activities
- 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 degree in biomedical engineering, medical technology, or a relevant technical field
- Over 5 years of experience in the medical device industry or other regulated fields, including more than 3 years in QARA roles
- Knowledge of medical device development and applicable standards (ISO 13485, ISO 14971, IEC 62304)
- Familiarity with MDR and FDA requirements
- Good understanding and work experience from software company or software project
- Understanding of design control, verification, and validation processes
- Experience in documentation creation; experience with software documentation is considered a plus
- Strong communication skills, ability to work with customers, and a self-driven mindset – you manage your own projects independently
- Familiarity with AI applications or cybersecurity in the context of medical devices is seen as a plus
- Experience with Atlassian Confluence, Jira, or other ALM (Application Lifecycle Management) tools is seen as a plus
- Experience with software development and Agile methodologies such as Scrum is seen as a plus
What we offer
- Meaningful work alongside highly skilled experts in the field
- Excellent employee benefits including comprehensive occupational healthcare and insurance coverage, lunch-, sports-, wellbeing-, and culture benefits
- Hybrid working opportunities and flexible working hours
If you want to join an interesting and growing company in the field of healthcare technology, please send your application and CV with salary wishes via our recruitment system as soon as possible, but no later than May 25. But do not wait too long, as we will start to go through applications already during the application period!
