NonStop Consulting
- Location:
- Boskoop – Zuid-Holland, Nederland, Netherlands
- Salary:
- Negotiable
- Type:
- Permanent
- Main Industry:
- Search Health, Nursing & Social Services Jobs
- Advertiser:
- NonStop Consulting
- Job ID:
- 131929307
- Posted On:
- 20 May 2025
Quality Assurance Specialist – Medical Devices / IVD, Rotterdam-Utrecht region, the Netherlands
ISO 13485 | Risk Management | CAPA | Auditing
Shape quality, shape patient care.
An internationally active organization within the medical device and diagnostics field is seeking a Quality Assurance Specialist to join its growing QA/RA team. In this key role, you’ll help drive quality across all business functions and support continuous improvement efforts that impact both patients and professionals across the EMEAI region.
You will work closely with cross-functional teams to maintain and improve the Quality Management System (QMS) in compliance with ISO 13485, lead internal audits, and manage essential QA processes such as CAPA, risk management, and complaint handling.
Your Impact
Maintain and enhance the QMS in accordance with ISO 13485 and other applicable standards
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Plan, execute, and follow up on internal audits across departments
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Support and drive both product and process risk management activities
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Analyze quality data and identify improvement opportunities
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Lead or support improvement projects across functions
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Support and prepare for external audits, ensuring full audit readiness
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Contribute to core quality processes including CAPA, customer complaints, and change control
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Deliver quality-related training to internal stakeholders and ensure procedural adherence
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Track and report on key quality metrics to drive performance transparency and action
Your Profile
Bachelor’s degree in a relevant scientific or technical discipline
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Minimum of 3 years’ experience in a QA role within the medical device, pharmaceutical, or IVD sector
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Solid understanding of ISO 13485 and QMS principles
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Experience conducting internal audits and managing CAPA and risk management
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Analytical mindset with the ability to interpret data and identify root causes
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Fluent in English, both written and spoken
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Strong collaboration and communication skills
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Proficiency in Microsoft Office and quality documentation systems (experience with QA platforms is a plus)
What You Can Expect
A purpose-driven role where your work supports diagnostic innovation and patient care
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A collaborative, international work culture that values quality, trust, and ownership
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Opportunities for professional growth within a fast-evolving environment
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Competitive employment conditions and the chance to make a tangible impact
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