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Job type: Permanent

Discipline: Senior/Director & VP

Location: Belgium

Are you driven to raise quality standards and deliver meaningful improvements in healthcare? Do you enjoy leading diverse teams and shaping strategic initiatives across global markets?

��Ƶ is seeking a Director of Quality Assurance to provide strategic leadership for the Quality Management System, ensuring compliance with global and regional regulations. You will lead a diverse team, drive continuous improvement initiatives, and foster a customer-focused culture. This position also involves collaborating with cross-functional teams to standardize and expand international quality systems.

Responsibilities:

Lead and drive the Quality team, fostering growth, collaboration, and high performance.
Ensure the QMS aligns with ISO 13485, 21 CFR, MDR-IVDR, UK CA Marking, and other relevant regulations.
Collaborate with Regulatory, R&D, Supply Chain, Legal, and Commercial teams to harmonize processes and achieve quality objectives.
Drive Lean Six Sigma and data-driven initiatives to manage non-conformances, CAPAs, complaints, and post-market surveillance.
Promote a customer-centric mindset, embedding customer needs into all quality activities.
Act as the primary contact for regulatory authorities, notified bodies, and auditors across EMEA.
Assess organizational structure, address skill gaps, and coach team members to build a world-class quality function.
Proactively identify and mitigate quality risks while staying ahead of regulatory changes and industry best practices.
Provide annual training on GMP and audit readiness.

Key Skills and Requirements:

Expertise in medical device quality management with knowledge of EMEA regulations and standards, including ISO 13485, 21 CFR, and MDR-IVDR.
Bachelor's degree in engineering or a related field; advanced degrees (e.g., Master's, MBA) are preferred.
Proven leadership experience managing large, diverse teams across multiple countries and cultures.
Strong analytical, problem-solving, and decision-making skills.
Excellent communication and influencing abilities at all levels.
Collaborative mindset with the ability to thrive in a global, matrixed environment.
Commitment to continuous improvement and fostering a culture of quality.
Fluency in English; additional languages are a plus.
Willingness to travel across the EMEA region (approximately 15%).

If you are having difficulty in applying or if you have any questions, please contact Nathan Berkley at n.berkley@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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