Quality Assurance Engineer, Distribution (EMEA)
As a leader in medical technology, we are dedicated to improving health outcomes through innovation, integrity and uncompromising quality.
We are now looking for an experienced Quality Assurance Engineer to join our team in Zaventem, Belgium. As Quality Assurance Engineer specializing in distribution, you will play a vital role in upholding product integrity across the supply chain. You will be responsible for managing distributor relationships, implementing robust quality assurance measures and ensuring full compliance with regulatory requirements, quality standards and Good Distribution Practices (GDP).
Quality Compliance: ensure audits, validations, and other quality activities are completed to maintain the effectiveness of Hologic's Quality System
Documentation & Reporting: maintain comprehensive records of distributor compliance, including assessments, quality agreements, audits, and corrective actions
Stakeholder Engagement: serve as the primary contact for distributor quality-related inquiries, providing expert guidance and regular updates
Continuous Improvement: develop and track metrics and KPIs to monitor distributor quality performance and support ongoing improvement initiatives
Audit Support: provide QA expertise during internal and external audits
Background in Engineering, Quality Assurance, Supply Chain Management, Logistics or a related field
Experience in medical device manufacturing or a related industry, ideally in a quality-focused role
Knowledge of Good Distribution Practices (GDP), ISO 9001/13485, EU MDR/IVDR and medical device regulations
Proven experience in root cause analysis, risk assessment, CAPA and audit processes
Adaptability to change and the ability to work both independently and as part of a collaborative team
If you're excited by the opportunity to leverage your quality assurance expertise in a fast-paced, mission-driven company, we want to hear from you.