Quality Engineer

il y a 4 semaines


Laeken, Belgique Vivid Resourcing Temps plein

Quality Engineer 📍 Location: Belgium 🏥 Industry: MedTech/Pharm/Medical Devices 💼 Type: Full-time, Permanent (Hybrid/On-Site) We are seeking a Quality Assurance & Validation Specialist to help ensure that all biomedical products are manufactured, packaged, stored, and distributed in full compliance with current Good Manufacturing Practices (cGMPs). You'll join a collaborative team and report to the Quality and Compliance Manager Biomedical to uphold quality and drive improvements across our operations. AREA OF RESPONSIBILITY AND RELATED TASKS: • Quality Assurance · Disposition of finished product batches & preparation of certificates of analysis · Incoming release of materials and packaging components · Investigation and resolution of non-conformances, deviations, and complaints · Approval of change controls and supplier qualifications · Management of specifications, QMS documentation and training program · Performing internal audits · Support during customer and authority audits, including CAPA follow-up · Documentation support towards customers • Validation · Development of validation masterplans, protocols (IQ/OQ/PQ) and related documentation · Execution of validation tests and coordination with external partners · Oversight of process validation activities and QC results · Ownership of re-qualifications and centralized validation archive · Contribution to risk assessments (FMEA)• Salary + Benefits -Up To €70,000-Meal Vouchers -Eco Vouchers -Mobility Budget -Group insurance -Clear career path & development plan • PROFILE · Professional years of experience in the Medical or Pharm industry with working knowledge of GMP (EU & US)· Skilled in root cause analysis and structured problem-solving · Strong communicator with the ability to influence and collaborate across teams · Proficient in Dutch and English Organized, detail-oriented, and proactive • WE OFFER THE OPPORTUNITY AND CHALLENGE · Impact: Your expertise will directly shape product quality and validation, fueling innovation in life sciences. · Growth in a Global Leader: Be part of an international organization recognized for its pioneering role in gelatin and collagen for biomedical applications. · Learning That Lasts: Expand your skill set in GMP compliance, Quality Management Systems and validation technologies in a supportive environment.


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