QA Officer, SaMD (Hybrid) – Global Audits & CAPA

skinvision1; Amsterdam; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid working policy

Team events

Unlimited skin checks

Job summary

SkinVision is seeking a Quality Assurance Officer to own and enhance the QMS in line with ISO 13485 and regulatory SaMD requirements. You will plan and lead internal and external audits, coordinate MDSAP and notified body activities, and drive CAPA and complaint handling across the organisation.

You will work with ISMS and regulatory functions to maintain compliance, support supplier qualification, and contribute to post-market surveillance and QA metrics, while coaching junior team members in a

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Quality Management, or related discipline.
• Minimum of 5 years in Quality Assurance within medical devices, SaMD, or similarly regulated environment.
• Proven experience building, maintaining, and improving a QMS in accordance with ISO 13485.

Responsibilities

• Own and drive the Quality Management System (QMS) in line with ISO 13485 and SaMD requirements.
• Plan, lead, and support internal and external audits including MDSAP and notified body assessments.
• Coordinate audit cycles across jurisdictions (US, Canada, Australia, etc.).
• Manage CAPA process end-to-end and investigate non-conformities and complaints.
• Collaborate with Safety and Risk Management to integrate QA into product lifecycle.
• Oversee document control and change management to ensure audit readiness.
• Coordinate supplier qualification and periodic re-assessment.
• Support software lifecycle quality activities per IEC 62304 for SaMD.
• Contribute to post-market surveillance and QA metrics reporting.
• Coach and mentor junior QA team members; promote QA culture.

Skills

ISO 13485

MDSAP

ISO 14971

IEC 62304

EU MDR

Audit leadership

CAPA management

Regulatory inspections

English fluency

Education

Bachelor's or Master's in Life Sciences

Quality Management background

Job description

SkinVision is seeking a Quality Assurance Officer to own and enhance the QMS in line with ISO 13485 and regulatory SaMD requirements. You will plan and lead internal and external audits, coordinate MDSAP and notified body activities, and drive CAPA and complaint handling across the organisation.

You will work with ISMS and regulatory functions to maintain compliance, support supplier qualification, and contribute to post-market surveillance and QA metrics, while coaching junior team members in a