QA/RA Manager

Innokas Medical Oy; Oulun seutukunta; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Meaningful work with cutting-edge tech

Supportive team environment

Deepening expertise in MDSW and cyber

Comprehensive employee benefits

Flexible hours & hybrid model

Job summary

Innokas Medical Oy is seeking an experienced QA/RA Manager to guide customers in bringing new medical devices to market. You will ensure software safety, cybersecurity, and regulatory compliance across the lifecycle, collaborating with a skilled QA/RA team.

The role emphasizes IEC 62304, ISO 13485/14971, MDR/IVDR, and FDA expectations, with hybrid work from Espoo or Kempele. Fluent English and strong technical writing are essential.

Qualifications

• University degree in a technical or life science field.
• Strong QA/RA experience in medical devices or IVD.
• Expertise in MDSW development and lifecycle (IEC 62304).
• Cybersecurity expertise for medical devices and risk assessments.
• Familiarity with ISO 13485, ISO 14971, MDR/IVDR and FDA.

Responsibilities

• Lead QA/RA activities in customer projects focusing on software and cybersecurity.
• Ensure compliance with applicable standards and regulations.
• Support software lifecycle activities and cybersecurity work (risk assessments).
• Plan and execute risk management for software/connected devices.
• Define product requirements with customers and establish design controls.
• Support verification, validation, and regulatory documentation.
• Contribute to internal audits and continuous improvement.

Skills

QA/RA management

MDSW development

IEC 62304

cybersecurity risk assessments

regulatory requirements

risk management (ISO 14971)

regulatory standards (ISO 13485, MDR,

Education

Biomedical engineering

Software engineering

Medical technology

Job description

Innokas is a growing Finnish CDMO trusted by companies across the Nordics and Europe to develop smart solutions for mission‑critical industries, including healthcare, industrial high‑tech, defense, and dual‑use applications. As part of the value‑driven, family‑owned Paree Group, we deliver technology design projects and products while supporting the entire lifecycle from concept to completion, covering design, development, manufacturing, quality assurance, and digital solutions. Together with our customers, we transform their ideas into high‑quality end products. We have offices in Finland (Kempele and Espoo) and in Estonia (Tallinn). Learn more at www.innokas.eu

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

In this role, you will help our customers bring new medical devices to market. Your focus will be on ensuring that solutions, especially Medical Device Software (MDSW) and software driving or influencing the use of a medical device, are safe, secure, effective, and compliant with applicable standards and regulations. You will take a leading role in guiding customers through the full development lifecycle, with particular emphasis on cybersecurity, software lifecycle management, and regulatory compliance. You will work as part of a friendly and highly skilled QA/RA team and act as a trusted advisor for our customers.

This is a permanent position located in Espoo or Kempele. This role follows a hybrid working model. We hope you can work from the office on a weekly basis, with onsite days agreed flexibly together with your team.

Your main responsibilities

Your responsibilities will vary depending on customer needs, but may include for example:

• - Leading QA/RA activities in customer projects, with emphasis on software and cybersecurity
• - Ensuring compliance with applicable standards and regulations
• - Supporting software lifecycle activities (IEC 62304) and cybersecurity work such as risk assessments
• - Planning and executing risk management (ISO 14971), especially for software and connected devices
• - Defining product requirements together with the customer, establishing design controls and traceability, ensuring documented evidence for regulatory requirements such as GSPR (general safety and performance requirements).
• - Supporting verification and validation, particularly for software systems
• - Implementing quality management systems, conducting internal audits and supporting continuous improvement
• - Creating regulatory strategies, including product classification and defining market approval pathways

What we expect from you

• - Relevant university degree in e.g. biomedical engineering, software engineering, medical technology, or another technical or life science field
• - Strong experience in QA/RA within medical devices or IVD
• - Solid expertise in MDSW development and lifecycle processes (IEC 62304)
• - Strong competence in medical device cybersecurity, including risk assessments, threat modeling, and regulatory expectations
• - Good understanding of key standards and regulations such as ISO 13485, ISO 14971, MDR, IVDR, and FDA requirements
• - Experience in design control, verification and validation, and creating technical documentation
• - Familiarity with AI applications in the context of medical devices is considered an advantage
• - Customer-oriented mindset with strong communication and stakeholder collaboration skills
• - Structured, proactive, and independent way of working
• - Excellent English skills and strong technical writing abilities. Finnish language skills are considered an advantage.

What we offer

• - Meaningful work with cutting‑edge medical technologies, especially in software‑driven and connected devices
• - A highly skilled and supportive team environment
• - Opportunities to deepen your expertise in MDSW, cybersecurity, and evolving regulatory requirements
• - Comprehensive employee benefits including occupational healthcare, insurance, and wellbeing benefits
• - Flexible working hours and hybrid work model

Project assignment and role start

Your first project will be defined based on an upcoming customer assignment. As Innokas operates as a CDMO with a diverse project portfolio, your responsibilities will be tailored to match your expertise, with strong focus on software‑driven medical devices and cybersecurity from day one. You will also have the opportunity to expand your role as projects evolve.

For further information about the position, please contact Sami Melkoniemi, Head of Engineering and QARA, at [phone]. Sami will be available for calls on 11 August, 10:00-11:00, and 18 August, 10:00-11:00.

At Innokas, we are committed to building a work community where everyone feels welcome and valued. We believe that diverse backgrounds, perspectives and experiences strengthen our thinking, foster innovation and support better decision‑making. We welcome applicants from all backgrounds.

Relevant university degree in biomedical engineering, software engineering, medical technology, or another technical or life science field, Strong experience in QA/RA within medical devices or IVD, Solid expertise in MDSW development and lifecycle processes (IEC 62304), Strong competence in medical device cybersecurity, including risk assessments and threat modeling, Good understanding of ISO 13485, ISO 14971, MDR, IVDR, and FDA requirements, Experience in design control, verification, validation, and technical documentation, Customer-oriented mindset with strong communication and stakeholder collaboration skills, Structured, proactive, and independent way of working, Excellent English skills and strong technical writing abilities