Quality Assurance Specialist

Quality that shapes patient care

At Sakura Finetek Europe, quality is at the heart of everything we do. As a trusted partner in cancer diagnostics, we deliver innovative and precise solutions that help laboratories around the world perform at their best. To continue building on that promise, we're looking for a Quality Assurance Specialist to join our team.

In this role, you'll play a key part in maintaining and improving our Quality Management System (QMS), ensuring compliance with relevant ISO standards. You will lead internal audits, support product and process risk management, and help us identify and act on improvement opportunities—across functions and throughout the EMEAI region.

This is a vital position within our Quality Assurance & Regulatory Affairs team, reporting to the Manager RA&QA.

Your impact

• Maintain and continuously improve the QMS in line with ISO 13485 and other applicable standards

• Plan, conduct, and follow up on internal audits across the organisation

• Support both product and process risk management activities

• Analyse quality data and identify areas for system and process improvement; and assist in the development and execution of improvement projects and programs

• Collaborate with external auditors during on-site audits and ensure audit readiness and success.

• Contribute to and manage Quality processes such as CAPA (Corrective and Preventive Actions), customer complaint and change management.

• Assist in the development and delivery of training for cross functional teams in quality-related procedures and processes

• Management and reporting of Quality measures and metrics

What you bring

• A bachelor’s degree in a relevant field

• At least 3 years of experience in a QA role within the pharmaceutical, medical device or IVD industry

• Solid working knowledge of ISO 13485 and quality system requirements

• Hands-on experience with internal audits, CAPA, and risk management

• Strong analytical skills and the ability to interpret data to drive improvements

• Fluent in Dutch and English, both written and spoken

• Strong interpersonal skills with the ability to work across teams and functions

• Experience with QA tools, documentation systems, and Microsoft Office (experience with QA applications/databases is a plus)

What we offer

• A purpose-driven role in a company that directly contributes to advancing cancer diagnostics

• A collaborative, international work environment where quality and innovation go hand in hand

• Opportunities to grow personally and professionally in a team that values trust and ownership

• Competitive employment conditions, with room to make a real impact

Are you ready to help us elevate quality and compliance to the next level?
We look forward to receiving your application.

Apply today by submitting your CV and cover letter down below. Let's shape the future of diagnostics—together.