Requirements: English
Company: Cure Talent
Region: Alphen aan den Rijn , South Holland
Salary: 77,000 to 92,000 per annum / 6400 to 7600 gross monthly
Cure Talent is thrilled to partner with a leading IVD distributor who, due to their exceptional continued growth, have an exciting opportunity for a Quality Assurance Specialist to join their team.
This is a hybrid role with the expectations of being on site 2 days a week.
In this role, you will play a vital role in maintaining and improving the companys Quality Management System (QMS), ensuring compliance with ISO 13485 and other applicable standards. Youll be responsible for leading internal audits, supporting risk management, and managing quality processes across the EMEAI region.
Key Responsibilities:
- Maintain and improve the QMS in accordance with ISO 13485 and related standards
- Lead and follow up on internal audits across departments
- Support product and process risk management activities
- Analyse quality data and drive improvement projects
- Manage CAPA, customer complaints, and change control processes
- Prepare for and support external audits, ensuring audit readiness
- Deliver training on quality procedures to cross-functional teams
- Monitor and report on key quality metrics
What You Will Need:
- Bachelors degree in a relevant scientific or technical discipline
- Minimum of 3 years experience in a QA role within IVD, medical devices, or pharmaceuticals
- Strong knowledge of ISO 13485 and associated quality system requirements
- Hands-on experience with audits, CAPA, and risk management
- Analytical mindset with the ability to interpret data and drive continuous improvement
- Fluent in Dutch and English, both spoken and written
- Strong interpersonal skills and experience working cross-functionally
- Proficiency in QA systems, tools, and documentation platforms
If you are a quality-driven professional looking to contribute to a purpose-led organisation focused on advancing cancer diagnostics, we would love to hear from you!