Senior QA/RA Lead: Audits, CAPAs & QMS Impact

Eurotrol B.V.; Netherlands; Remote; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Market-competitive salary

Flexible work environment

Job summary

Eurotrol B.V. is seeking a Senior QA/RA Specialist to act as a strategic partner, supporting product development, ensuring regulatory compliance, leading audits and CAPAs, and driving continuous improvement of the QMS. You will guide quality decisions and mentor QA/RA team members.

With a Master’s degree in Life Sciences or related field and 4+ years in QA/RA, you will apply ISO 13485 and IVDR, influence stakeholders, and lead efforts to safeguard healthcare product quality.

Qualifications

• Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related discipline.
• 4+ years of experience in QA/RA within medical device or IVD.
• Proven experience supporting product development and regulatory compliance.
• Strong knowledge of ISO 13485, IVDR, and audit practices.
• Demonstrated experience leading CAPAs and audits.

Responsibilities

• Support product development, design transfer, and complex product changes.
• Interpret and apply regulatory requirements (including IVDR) across the organization.
• Lead and assess complex CAPAs, including effectiveness checks and trend analyses.
• Prepare for, support, and participate in internal and external audits.
• Drive continuous improvement initiatives within the QMS.
• Coach and mentor junior and medior QA/RA colleagues.
• Provide strategic input on quality and compliance topics.

Skills

Regulatory affairs

Quality management

CAPA management

Audit leadership

Regulatory compliance

Stakeholder influence

Education

Master's degree in Life Sciences or related field

Job description

Eurotrol B.V. is seeking a Senior QA/RA Specialist to act as a strategic partner, supporting product development, ensuring regulatory compliance, leading audits and CAPAs, and driving continuous improvement of the QMS. You will guide quality decisions and mentor QA/RA team members.

With a Master’s degree in Life Sciences or related field and 4+ years in QA/RA, you will apply ISO 13485 and IVDR, influence stakeholders, and lead efforts to safeguard healthcare product quality.