Junior Quality Assurance Officer

For this role we will only consider candidates who are currently based in the Netherlands.

About SkinVision:

Skin cancer cases are growing at an alarming rate fact 1 in 5 people will get skin cancer but only 3% of the high-risk population is known to the health authorities. At SkinVision we are on a mission to save the lives of 250000 people in the next ten years by revolutionizing skin care management. Our technology allows users to take ownership of their skin health recognizing (early) signs of skin cancer from anywhere at any time by combining the recommendations of AI and dermatologists.

Junior Quality Assurance Officer at SkinVision:

As a Jr. Quality Assurance Officer you will primarily support the ongoing development operation and improvement of SkinVisions ISO 13485 - compliant Quality Management System. While the role is in Quality Assurance you will also assist with selected Regulatory Affairs activities to ensure our AI-based SaMD remains compliant across different regulatory frameworks.

This role is ideal for someone early in their career who wants to develop deep expertise in medical device quality and regulatory frameworks. You will be mentored by several experienced QA & RA experts.

What You will Do:

Quality Assurance

• Support the day-to-day operation of the Quality Management System

• Assist with document control change management and training activities

• Help prepare and participate in internal audits and external audit readiness

• Support CAPA non-conformities complaints and quality improvement processes

• Assist with risk management activities (ISO 14971)

• Assist with onboarding and evaluating suppliers and service providers

• Help identify opportunities to improve processes templates and workflows

• Support cross-team initiatives to strengthen SkinVisions quality culture

Regulatory Affairs

• Assist in compiling maintaining and updating regulatory documentation and tracking requirements across SkinVisions target markets (e.g. EU MDR TGA) to support ongoing compliance.

• Supports post-market surveillance activities (CAPAs complaints risk management) and vigilance reporting.

• Support communication and coordination with the Authorized Representative as well as relevant regulatory authorities

• Based in the Netherlands

• Up to 2 years of experience in Quality Assurance and/or Regulatory Affairs preferably within medical devices or a similarly regulated environment

• Bachelors degree in Life Sciences Biomedical Engineering Regulatory Affairs Quality Management or related fields. An advanced degree is a plus

• Familiarity with building and maintaining QMS in accordance with the ISO 13485 standard.

• Experience with notified body audits and regulatory inspections

• Fluent in English additional languages are a plus

• Detail-oriented critical excellent communication and organisational skills

• Able to work both independently and in a team

• Technology savvy as SkinVision is a medtech company

• Foundational understanding of international standards such as ISO 13485 and ISO 14971

• Foundational understanding of EU MDR

• Good analytical skills attention to detail and structured working style

• Strong communication and collaboration skills

Nice to have:

• Knowledge of ISO 27001 and information security practices

• Knowledge of IEC 62304

• Experience working with software as a medical device (SaMD) or cloud-based digital health platforms

What we offer you:

• 3 office days per week with a healthy lunch and 2 days of working from home.

• A competitive salary based on your experience.

• Join our enthusiastic and professional team with colleagues from all over the world.

• A dynamic and rapidly growing scale-up in Amsterdam.

• Unlimited skin checks for you.

• Regular team events such as weekly drinks and frequent dinners.

Ready to use your skills to make a lasting impact in healthcare Join us and help make advanced skin health accessible to everyone.