Quality Assurance Engineer

Quality Assurance Engineer, Distribution (EMEA)Role location: Zaventem, BelgiumTravel: 10-15%At Hologic, we are driven by our purpose to enable healthier lives everywhere, every day. 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).Role Responsibilities:Distributor Management: evaluate and oversee new and existing distributors to ensure they meet both regulatory and organizational requirementsQuality Compliance: ensure audits, validations, and other quality activities are completed to maintain the effectiveness of Hologic’s Quality SystemCross-Functional Collaboration: work closely with Regulatory Affairs and other departments to identify local distribution requirements and ensure compliance regarding product storage, handling, transportation, traceability and reportingDocumentation & Reporting: maintain comprehensive records of distributor compliance, including assessments, quality agreements, audits, and corrective actionsRisk & Non-Conformance Management: investigate non-conformances and implement corrective and preventive actions to eliminate re-occurrenceStakeholder 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 initiativesSOP Development: participate in the creation and maintenance of SOPs related to distribution activitiesAudit Support: provide QA expertise during internal and external auditsKnowledge, skills and experience: Background in Engineering, Quality Assurance, Supply Chain Management, Logistics or a related fieldExperience in medical device manufacturing or a related industry, ideally in a quality-focused roleKnowledge of Good Distribution Practices (GDP), ISO 9001/13485, EU MDR/IVDR and medical device regulationsProven experience in root cause analysis, risk assessment, CAPA and audit processesExperience with logistics and distribution processes will be advantageousExcellent communication, negotiation and interpersonal skills—able to engage effectively with both internal and external stakeholdersAnalytical and problem-solving mindset with a proactive and organized approach to managing multiple prioritiesAdaptability to change and the ability to work both independently and as part of a collaborative teamIf 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. Apply today and join us at Hologic!#associate