QA Manager - Medical Devices, Apeldoorn, the Netherlands
Scope of the Role
The QA Manager is responsible for overseeing all quality assurance activities on site, ensuring compliance with international standards and regulations, and safeguarding certifications. Acting as the site's Management Representative, this role provides guidance to leadership and stakeholders on all matters related to quality and compliance.
Position Overview
The QA Manager is the central point of contact for quality-related issues impacting manufacturing, design control, and regulatory compliance. This person contributes to both operational execution and long-term strategy, while embedding best practices throughout the organization. The position also includes designated responsibilities under the EU Medical Device Regulation (MDR 2017/745, Article 15).
Key Responsibilities
Lead the development, implementation, and continuous improvement of the Quality Management System (QMS).
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Monitor and report on QMS performance to senior management, recommending system enhancements where needed.
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Facilitate audits, inspections, and regulatory reviews; act as the primary contact for notified bodies and external regulators.
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Support product registrations and ensure compliance with MDR and ISO 13485 requirements.
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Collaborate across functions such as R&D, Clinical Affairs, and Marketing to align quality objectives with business priorities.
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Oversee validation protocols for equipment and processes (IQ, OQ, PQ).
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Manage QA activities across document control, inspections, CAPA, complaint handling, and nonconformances.
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Direct, coach, and develop a team of QA and QC professionals; ensure clear objectives and performance management.
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Provide training and professional development opportunities to strengthen compliance expertise.
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Lead the internal audit program and represent the site in external audits.
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Assess and approve new suppliers, monitor vendor performance, and manage QA-related procurement.
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Contribute to departmental budgeting and forecasting for compliance-related activities.
Qualifications & Skills
Degree in chemistry, biochemistry, biotechnology, materials science, or related technical field.
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Minimum of 7 years' experience in quality assurance within the medical device industry.
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Demonstrated expertise in ISO 13485, MDR, and regulatory inspections.
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Experience across the product lifecycle, from development to distribution.
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Proven leadership background (3-5 years) with responsibility for hiring, budgeting, and team performance.
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Internal auditor certification preferred.
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Strong interpersonal skills; able to collaborate across functions and cultures.
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Excellent communication (English, verbal and written), problem-solving, and organizational skills.
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Ability to manage multiple priorities in a fast-paced environment, maintaining focus on compliance and quality outcomes.
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High personal integrity, with a pragmatic and results-oriented mindset.
Other Details
Full-time position with occasional domestic and international travel (up to 10%).
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Hybrid setup possible, but on-site presence is preferred.
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