Quality Assurance Officer

SkinVision; Amsterdam; Hybrid; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid working policy

Competitive salary

Amsterdam scale-up culture

Team events

Unlimited skin checks

Job summary

SkinVision, Amsterdam-based medical-tech scale-up, seeks a Quality Assurance Officer to own the QMS, coordinate audits, and drive CAPA and complaint handling across the product lifecycle. You will collaborate with Safety, Regulatory, Development and QA teams to ensure ISO 13485 compliance and SaMD quality.

Requirements include 5+ years in medical device QA, experience with audits (notified bodies, MDSAP) and FDA 21 CFR 820 familiarity, as well as strong English communication and project

Qualifications

• 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 hosting audits (notified body, MDSAP) and regulatory inspections, including FDA 21 CFR 820 awareness.
• Fluent in English (written and spoken).

Responsibilities

• Own and maintain SkinVision's Quality Management System (QMS) in line with ISO 13485 and SaMD requirements.
• Plan, lead, and support internal and external audits, including notified body and MDSAP assessments.
• Manage CAPA, non-conformities, complaint handling, and documentation across the organisation.
• Coordinate supplier qualification and evaluation, performing periodic re-assessments.
• Support software lifecycle quality per IEC 62304 for SaMD and participate in PMS data review.

Skills

ISO 13485 compliance

MDSAP

Regulatory audits

CAPA management

Complaint handling

ISO 14971

IEC 62304

EU MDR

QA leadership

English proficiency

Education

Bachelor's or Master's in Life Sciences/Quality

Job description

About SkinVision

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.

Quality Assurance Office at SkinVision

SkinVision offers scientifically proven technology that empowers people to assess their skin for signs of skin cancer. As an AI-based Software as a Medical Device, quality is central to everything we do.

The Quality Assurance Officer ensures that SkinVision's Quality Management System is effectively implemented, maintained, and continuously improved in line with ISO 13485, MDSAP, and applicable requirements for Software as a Medical Device (SaMD). This role takes ownership of core QA processes, including audits, CAPA, and document control, and acts as a key point of contact for quality matters across the organisation. You will work closely with other members of the QA team, the Safety and Risk Management Specialist, Regulatory Affairs, Development, and other functions to ensure quality, safety, and regulatory requirements are effectively embedded throughout the organisation and product lifecycle.

What You Will Do

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


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


• 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);


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


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


• 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;


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


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


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


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


• Prepare quality metrics and reports for management review;


• Coach and support junior QA team members;


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

ISMS Responsibilities

• Support the maintenance of ISMS documents;


• Ensure compliance with ISO 27001 and NEN7510;


• Support internal and external audits;


• Support supplier control activities;


• Support non-conformity management.

Your profile

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.

What We Offer

• A competitive salary, additional benefits, and a hybrid working policy;


• A vibrant, dynamic, and rapidly growing scale-up in Amsterdam;


• An enthusiastic, professional, and international team;


• Regular team events, including off-sites and fun activities;


• Unlimited skin checks for you.