QA Lead – SaMD & ISO 13485 Compliance

ION Develop Different; Amsterdam; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Hybrid working policy

Team events

Unlimited skin checks

Job summary

SkinVision, an Amsterdam-based AI-powered medical device company, seeks a Quality Assurance Officer to own and advance the QMS for SaMD in line with ISO 13485 and regulatory requirements. You will coordinate audits, CAPA, and supplier controls, while guiding cross-functional teams on quality and safety across the product lifecycle.

You will interact with regulatory, development, and safety functions to ensure audit readiness, post-market surveillance, and effective quality governance across

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 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).

Responsibilities

• 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 external audits, including notified body assessments and MDSAP audits.
• Support the maintenance of MDSAP certification and coordinate audit cycles across applicable jurisdictions worldwide.
• 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 with the Safety and Risk Management Specialist on risk management activities in accordance with ISO 14971.
• Own document control and change management processes, ensuring documentation stays current and audit-ready.
• Manage supplier qualification and evaluation programme, including periodic reassessment.
• 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.
• Support ISMS documents and ISO 27001 / NEN7510 compliance.
• Assist audits and supplier control activities; support non-conformity management.

Skills

Quality management

Regulatory audits

CAPA management

Audit leadership

English fluency

Education

Life Sciences / QA degree

Job description

SkinVision, an Amsterdam-based AI-powered medical device company, seeks a Quality Assurance Officer to own and advance the QMS for SaMD in line with ISO 13485 and regulatory requirements. You will coordinate audits, CAPA, and supplier controls, while guiding cross-functional teams on quality and safety across the product lifecycle.

You will interact with regulatory, development, and safety functions to ensure audit readiness, post-market surveillance, and effective quality governance across