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BrusselsHybrid40 hours/week<3months
For a MedTech organization, a QA Specialist is sought to support the assessment, qualification, and ongoing management of 3PLs, Logistics Service Providers, and Distributors. Your work will play a key role in maintaining product integrity, supporting compliance, and strengthening distribution quality processes.
What you do
- Assess, qualify, monitor, and requalify Distribution Service Providers in line with regulatory and customer requirements.
- Maintain lifecycle oversight, including assessments, quality agreements, audits, mitigation plans, corrective actions, and compliance documentation.
- Support Distribution Service Provider 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, ISO 13485, 21 CFR Parts 11 and 820, and GDP.
- Support internal and external audits and cross-functional projects as required.
Profile
- 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.
Practical
- Languages: Fluent French or Dutch.
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