Quality Assurance Manager - Venlo/Nijmegen region
About the Role
We are looking for an experienced and forward-thinking Quality Assurance Manager to lead quality operations across our EMEA distribution network. This role is critical in ensuring the implementation, maintenance, and continuous improvement of a robust Quality Management System (QMS) in a multi-site, regulated environment.
Reporting into the global quality function, you will act as a strategic partner to Operations, Supply Chain, Regulatory, and Corporate Quality teams, fostering a culture of compliance, excellence, and continuous improvement. You will ensure alignment with ISO 13485, EU MDR, and other global regulatory standards while driving quality initiatives across the region.
Key Responsibilities
Provide strategic leadership for quality activities across multiple distribution centers in the EMEA region.
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Act as a trusted advisor to site stakeholders, ensuring strong cross-functional alignment.
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Champion a proactive, quality-first culture to drive operational excellence.
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Lead initiatives to simplify, standardize, and improve QMS processes.
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Allocate team resources to support quality, delivery, and cost objectives.
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Monitor and report on quality performance, risks, and improvement opportunities to senior leadership.
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Ensure audit readiness and compliance with ISO 13485, EU MDR, MDSAP, and other applicable standards.
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Oversee investigations, CAPA processes, and non-conformance management using structured problem-solving methodologies (A3, 8D, DMAIC).
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Identify and address systemic quality risks through data analysis and root cause investigation.
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Lead and develop a geographically dispersed quality team, fostering engagement, accountability, and high performance.
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Collaborate with global quality, regulatory, and supply chain counterparts to ensure alignment.
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Support integration projects that enhance efficiency and compliance within the supply chain.
Qualifications
Bachelor's degree in Engineering, Science, or a related technical field.
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Minimum 5 years' experience in Quality Assurance within a regulated distribution or manufacturing environment.
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At least 3 years in a leadership role managing quality professionals in a multi-site or matrixed organization.
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Proven track record in implementing and maintaining ISO 13485 or equivalent QMS.
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Experience with EU MDR, MDSAP, GMP, and relevant international standards.
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Proficiency in structured problem-solving (A3, 8D, DMAIC) and data-driven decision making.
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Strong influencing skills with the ability to manage priorities in complex environments.
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Excellent communication skills, with the ability to present effectively to senior leadership.
Preferred:
Experience in global or multi-regional organizations.
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Lean/Six Sigma certification or equivalent training.
Key Competencies
Strategic mindset with a practical, hands-on approach
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Collaborative leadership style and strong interpersonal skills
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Highly organized with excellent attention to detail
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Passionate about continuous improvement and operational excellence
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Resilient, adaptable, and solutions-oriented
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