QMS Specialist

Unity Partners on behalf of our MedTech partner

We are currently supporting our international MedTech partner in their search for a Quality Management System (QMS) Specialist to join their team. This is a hands-on, EMEA-level role that plays a key part in ensuring compliance, driving continuous improvement, and embedding quality and risk management across the organization.

As QMS Specialist, you'll be the subject matter expert for ISO 9001 and take ownership of developing and maintaining audit-ready management systems, supporting cross-functional process optimization, and contributing to operational excellence in a fast-paced, regulated environment.

Key Responsibilities

• Develop and maintain QMS and other operational management systems to ensure ISO 9001 compliance
• Lead and coordinate internal and external audits, including planning, reporting, and follow-up
• Drive corrective actions and root cause analysis for audit findings and quality issues
• Conduct risk assessments using methodologies such as FMEA and fault tree analysis
• Analyze KPIs and quality data to identify trends and improvement areas
• Manage documentation control and ensure audit readiness at all times
• Collaborate with business process owners across departments to maintain and improve documented processes
• Deliver QMS-related training and engage teams in compliance awareness
• Support the implementation of process improvements aligned with business goals
• Lead cross-functional resolution of CAPAs, SCARs, and other quality events

Your Profile

• Higher professional education in a relevant discipline
• 3+ years of experience improving quality management systems, ideally within MedTech or pharmaceuticals
• Experience with internal audits, ISO certification processes, and regulatory inspections
• Strong knowledge of ISO 9001 and quality/risk management frameworks
• Familiarity with FMEA, fault tree analysis, and other risk methodologies
• Excellent communication skills in English (Dutch is a plus)
• Confidence to work independently and collaboratively across multiple teams
• Experience leading QMS-related training sessions and stakeholder engagement

Organization & Offer

Our partner offers a chance to work on meaningful projects that directly support human health and diagnostics innovation. You will join a professional and collaborative international team dedicated to quality, compliance, and innovation.

You'll benefit from:

• A competitive salary based on experience
• 13th-month bonus and full pension contribution by the employer
• 28 vacation days
• A career with real purpose, supporting cutting-edge developments in remote diagnostics and medical technologies

INTERESTED?

For more information or to apply directly, please contact Christian Steenkamp at (0) or via email at