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QMS Specialist Capelle aan den IJssel • QTC Recruitment
Gevraagd
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40 uur
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HBO of hoger
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Medior/Senior
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Engels (taal)
Aanbod
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Vast contract
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13e maand, Pensioenregeling, Opleidingsbudget
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Deels thuiswerken
Vacature in het kort
Capelle aan den IJssel
Join a leading international medical device organization specializing in Ophthalmology as a Quality Management System (QMS) Specialist. Embrace a hybrid working policy while making a significant impact on quality and compliance. Find out how this role can provide the challenges you seek.
Over het bedrijf
QTC Recruitment
Volledige vacaturetekst
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.
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.
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
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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