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QMS Specialist

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QTC are partnered with a leading international active medical device organisation specialised in the Ophthalmology sector. We are on the lookout for a motivated Quality Management System (QMS) Specialist to provide technical guidance and expertise across the EMEA region to ensure compliance against ISO 13485 AND ISO 9001 standards.

Details

Medical Devices

Quality/RA

Capelle aan den IJssel - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

Key responsibilities for the include: Develop and maintain QMS policies aligned with ISO standards, preferably 13485 Plan and conduct internal/external audits; lead corrective actions and close findings. Conduct risk assessments (e.g., FMEA, fault tree analysis). Monitor KPIs to drive continuous improvement and operational efficiency. Lead initiatives to optimise processes and enhance compliance. Support departments in resolving CAPAs, SCARs, and nonconformities. Help process owners document and improve workflows. Escalate and manage compliance risks proactively. Deliver QMS training across teams. Manage tools for quality frameworks, tracking, and performance monitoring.

QTC logo icon what's needed

What you bring

What you bring:

 

  • Minimum HBO degree level
  • 3+ years working experience optimising QMS ideally in the medical device industry
  • Proven ability to plan and lead internal audits for compliance readiness
  • Familiar with risk management tools including FMEA
  • Experience with ISO certification processes and regulatory audits

QTC logo icon What we offer

What's in it for you

What's on offer:

 

  • Competitive Salary
  • 13th month
  • Full pension contribution
  • 28 holidays
  • Learning and Development Budget
  • Hybrid working policy

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