Quality Assurance Engineer, Distribution (EMEA)
Role location: Zaventem, Belgium
Travel: 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:
1. Distributor Management: evaluate and oversee new and existing distributors to ensure they meet both regulatory and organizational requirements
2. Quality Compliance: ensure audits, validations, and other quality activities are completed to maintain the effectiveness of Hologic’s Quality System
3. Cross-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 reporting
4. Documentation & Reporting: maintain comprehensive records of distributor compliance, including assessments, quality agreements, audits, and corrective actions
5. Risk & Non-Conformance Management: investigate non-conformances and implement corrective and preventive actions to eliminate re-occurrence
6. Stakeholder Engagement: serve as the primary contact for distributor quality-related inquiries, providing expert guidance and regular updates
7. Continuous Improvement: develop and track metrics and KPIs to monitor distributor quality performance and support ongoing improvement initiatives
8. SOP Development: participate in the creation and maintenance of SOPs related to distribution activities
9. Audit Support: provide QA expertise during internal and external audits
Knowledge, skills and experience:
10. Background in Engineering, Quality Assurance, Supply Chain Management, Logistics or a related field
11. Experience in medical device manufacturing or a related industry, ideally in a quality-focused role
12. Knowledge of Good Distribution Practices (GDP), ISO 9001/13485, EU MDR/IVDR and medical device regulations
13. Proven experience in root cause analysis, risk assessment, CAPA and audit processes
14. Experience with logistics and distribution processes will be advantageous
15. Excellent communication, negotiation and interpersonal skills—able to engage effectively with both internal and external stakeholders
16. Analytical and problem-solving mindset with a proactive and organized approach to managing multiple priorities
17. 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.