Quality Assurance Officer

Skin cancer is highly treatable when caught early, but limited access to specialist care and long wait times delay diagnosis, increasing the risk of late-stage cases and driving up treatment costs. SkinVision, founded in Amsterdam in 2012, exists to close that gap.

Our proprietary AI — certified as a Class IIa medical device under EU regulation, with over 90% sensitivity and 89% specificity — has already helped nearly 3 million people worldwide detect early signs of skin cancer. Today, SkinVision has a database of more than 6 million skin cancer images. High-risk cases are reviewed by a team of dermatologists, who support users in taking the right next step — from urgent care to a specialist referral. We are extending this further, connecting users faster to the specialist care they need.

We're a focused, international team, active globally, united by one goal: making early detection accessible to everyone, everywhere. If you join us, you're not just building a product — you're helping close the gap between a person noticing something and getting the care they need.

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  Own and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 and applicable SaMD regulatory requirements;

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  Plan, lead, and follow up on internal audits; prepare for and support external audits, including notified body assessments and MDSAP audits;

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  Support the maintenance of MDSAP certification and coordinate audit cycles across applicable jurisdictions worldwide (e.g. US, Canada, Australia, and other markets as SkinVision expands);

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  Manage the CAPA process end-to-end, including root cause analysis, effectiveness checks, and closure;

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  Manage non-conformities and complaint handling, ensuring timely investigation, documentation, and trend analysis;

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  Collaborate closely with the Safety and Risk Management Specialist on risk management activities in accordance with ISO 14971, providing QA input across the product lifecycle;

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  Own document control and change management processes, ensuring documentation stays current and audit-ready;

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  Manage the supplier qualification and evaluation programme, including periodic re-assessment;

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  Support software lifecycle quality activities in line with IEC 62304 for our AI-based SaMD;

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  Contribute to post-market surveillance activities from a QA perspective, including complaint trending and PMS data review;

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  Prepare quality metrics and reports for management review;

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  Coach and support junior QA team members;

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  Drive quality culture and training across departments, promoting operational excellence and ownership.

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  Support the maintenance of ISMS documents;

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  Ensure compliance with ISO 27001 and NEN7510;

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  Support internal and external audits;

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  Support supplier control activities;

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  Support non-conformity management.

Education:

• Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Quality Management, or a related discipline;

• Minimum of 5 years of experience in Quality Assurance within medical devices, SaMD, or another similarly regulated environment;

• Proven experience building, maintaining, and improving a QMS in accordance with ISO 13485;

• Experience preparing for and hosting notified body audits, MDSAP audits, and regulatory inspections;

• Experience with FDA regulations (e.g. 21 CFR 820) is a plus;

• Fluent in English (written and spoken).

Skills:

• Strong working knowledge of ISO 13485 and MDSAP requirements; familiarity with ISO 14971 and IEC 62304 is a plus;

• Understanding of EU MDR and the regulatory considerations specific to SaMD;

• Ability to independently lead audits and manage CAPA and complaint-handling processes;

• Detail-oriented, with the ability to notice patterns that may impact product quality and safety;

• Strong communication skills, able to translate quality requirements to technical and non-technical stakeholders;

• Project management and organisational skills;

• Ability to work independently, take ownership, and drive issues to closure;

• Coaching and mentoring skills;

• Team working skills.