Quality Specialist

Are you passionate about quality compliance and ensuring products reach customers safely and reliably Do you enjoy working with logistics partners solving problems and driving continuous improvement If so we have an exciting opportunity for you to join our team as a Quality Specialist based in Zaventem Belgium.

This is your chance to contribute to meaningful work in the medical device industry where your expertise will help ensure our products are stored handled transported and delivered in line with regulatory requirements Good Distribution Practices and Hologics quality standards.

As Quality Specialist you will support the assessment qualification and ongoing management of Distribution Service Providers including 3PLs Logistics Service Providers and Distributors. Your work will play a key role in maintaining product integrity supporting compliance and strengthening our distribution quality processes.

What to Expect:

• Assess qualify monitor and requalify Distribution Service Providers in line with regulatory and Hologic requirements.
• Maintain lifecycle oversight including assessments quality agreements audits mitigation plans corrective actions and compliance documentation.
• Support DSP quality activities including audits validation verification and Quality System requirements.
• Collaborate with Regulatory Affairs and cross-functional teams to confirm local distribution requirements for storage handling transportation traceability and reporting.
• Investigate distribution-related non-conformances and complaints including product damage and temperature excursions.
• Identify root causes and support corrective and preventive actions.
• Manage risks across the distribution network and support business continuity where required.
• Participate in change control activities related to DSPs routes packaging and storage conditions.
• Maintain accurate non-conformance records SOPs inspection records and validation documentation.
• Support metrics and KPIs to monitor DSP performance and escalate risks where appropriate.
• Identify opportunities to improve Quality System effectiveness in line with ISO 9001 ISOCFR Parts 11 and 820 and GDP.
• Support internal and external audits and cross-functional projects as required.

What We Expect:

• Bachelors degree in Engineering Quality Assurance Supply Chain Management Logistics or a related field.
• 3 years experience in medical device manufacturing or a related regulated industry preferably within Quality.
• Knowledge of Good Distribution Practices ISO 9001 ISO 13485 EU MDR/IVDR and medical device regulations.
• Experience with root cause analysis risk assessment CAPA and auditing.
• Experience with logistics and distribution processes is highly preferred.
• Strong communication and stakeholder management skills.
• Ability to work independently and collaboratively with internal and external partners.
• Good analytical problem-solving negotiation and persuasion skills.
• Ability to produce clear reports and define practical action plans.
• Proficiency with Microsoft Office tools; Power BI and AI tools are a plus.
• Experience with PLM and ERP systems is preferred.
• Proactive organized adaptable and able to manage multiple priorities.
• Strong ownership accountability integrity and continuous improvement mindset.
• Customer-focused approach with a strong commitment to quality.

Why Hologic

• Work on impactful projects that support product quality compliance and patient safety.
• Partner with internal teams and external providers to strengthen a reliable distribution network.
• Grow your career in a supportive collaborative and quality-driven environment.
• Competitive salary and benefits package including health insurance.

Travel Requirements: 10% per year
Language Requirements: Proficient in English written and oral. A second language is a plus.

Salary:gross per year

The final offer will depend on experience skills and alignment with internal pay addition we offer a comprehensive benefits package including pension and insurances.

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