Quality Assurance Specialist, Vierpolders

Job Details: Quality Assurance Specialist Full Time, Permanent Employee– Location: The Netherlands - Vierpolders.

Purpose As a Quality Assurance Specialist at BVI Vierpolders, you will play a key role in maintaining and improving our Quality Management System in compliance with international standards for medical device manufacturing. You’ll drive continuous improvement across the organization by conducting audits, implementing corrective actions, supporting changes processes, and more.

Key Responsibilities

Maintain, improve, and ensure compliance of the Quality Management System (QMS) with ISO 13485 and other applicable standards

Support the implementation of new or updated products, processes, and procedures in line with regulatory requirements

Manage non-conformities, complaints, and CAPAs, ensuring timely follow-up and documentation

Coordinate and conduct internal and supplier audits, and support external audits

Provide training and coaching to colleagues on quality-related topics

Contribute to Management Reviews and monitor quality performance metrics

Review and approve production releases and validation protocols/reports

Provide hands‑on quality support to operational departments on the production floor

Qualifications

Bachelor’s or Master’s degree (WO level) in Engineering, Biomedical Sciences, Chemistry, or a related field

Available to work on‑site in Vierpolders five days per week (full‑time presence required)

Fluent in Dutch and English; both written and spoken

1–3 years of experience in a quality or regulatory role

Knowledge ofISO 9001 is required; experience with ISO 13485 is a strong plus

Analytical mindset with strong attention to detail and a proactive, quality‑driven approach

A collaborative team player with excellent communication skills

Strong multitasking abilities; able to manage various subjects and responsibilities simultaneously

Auditing experience or certification (e.g., ISO 13485 lead auditor) is an advantage

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