Senior QA Lead, SaMD & ISO 13485 Expert (Hybrid)

ION; Amsterdam; Hybride; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Hybrid working policy

Hyatt Amsterdam office

Team events

Unlimited skin checks

Résumé du poste

SkinVision, a fast-growing Amsterdam-based AI medical device company, seeks a seasoned Quality Assurance Specialist to own the QMS and ensure ISO 13485 compliance across the product lifecycle. You will lead internal and external audits, coordinate MDSAP activities, and drive CAPA and complaint handling with a cross-functional team.

You will also maintain supplier qualification, support IEC 62304 for SaMD, and contribute to PMS and QA metrics.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Quality Management, or related field.
• 10+ years of experience in Quality Assurance within medical devices or SaMD.
• Proven experience building, maintaining, and improving a QMS per ISO 13485.
• Experience hosting audits (notified body, MDSAP) and regulatory inspections.
• Experience with FDA (21 CFR 820) is a plus.
• Fluent in English (written and spoken).

Responsabilités

• Own and continuously improve the Quality Management System (QMS) per ISO 13485 and SaMD requirements.
• Plan, lead, and support internal and external audits, including ongoing audits and MDSAP rounds.
• Maintain MDSAP certification and coordinate audit cycles across jurisdictions.
• Manage CAPA process end-to-end, including root cause analysis and closure.
• Handle non-conformities and complaint investigations with trend analysis.
• Collaborate with Safety and Risk Management on ISO 14971 and product lifecycle QA.
• Oversee document control and change management for audit-readiness.
• Manage supplier qualification and evaluations; re-assessments.
• Support software lifecycle quality per IEC 62304 for SaMD.
• Contribute to PMS, complaint trending, and QA metrics reporting.
• Coach and mentor junior QA team members and promote a quality culture.

Connaissances

ISO 13485

MDSAP

CAPA management

Audits

Regulatory inspections

Quality management

Software as Medical Device

Communication skills

Project management

Formation

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

Description du poste

SkinVision, a fast-growing Amsterdam-based AI medical device company, seeks a seasoned Quality Assurance Specialist to own the QMS and ensure ISO 13485 compliance across the product lifecycle. You will lead internal and external audits, coordinate MDSAP activities, and drive CAPA and complaint handling with a cross-functional team.

You will also maintain supplier qualification, support IEC 62304 for SaMD, and contribute to PMS and QA metrics.