Quality Assurance Assistant Operations

At SV Agency, you have a choice. First, look at our various job opportunities. However, SV Agency also offers you another option. Do you want to expand or enrich yourself? We're not just looking for colleagues who can delve deeply into their subject. We're also looking for colleagues we call "liaisons" who can combine our diversity with our services. to each other. and enrich our business.

SV Agency is the world's leading inspection, verification, testing and certification company. We are also the global benchmark for quality and integrity. This makes us very proud. This is thanks to nearly ⚠,⚠ colleagues worldwide, including more than ⚠,⚠ employees in Belgium alone. Our people give ⚠% every day and span a variety of expertise, industries and cultures. Our employees develop their own path within the company, services and expertise.

We are currently looking for a Quality Assurance Assistant at SV Agency ⚠ in Antwerp. You will be responsible for:

• Maintaining the internal medical device quality management system NB ⚠
• Managing daily quality assurance tasks
• Updating and maintaining documentation within the MDD, MDR and IVDR systems
• Managing databases
• Collaborating on general system documentation on the SV Agency website Bizzmine
• User communication and maintenance manage complaints, compliance inquiries and appeals
• Continuous improvement manage document control and records conduct quality assurance reviews of updated quality management system documents publish updated quality management system documents in Bizzmine undertake personal professional development and ensure that appropriate training records are updated
• Provide technical support to all areas of the company
• Maintain a thorough knowledge and understanding of SV Agency procedures, regulations, governing documents (e.g. MDCG) and external approval standards
• Support the development and maintenance of composite system documentation

Skills and knowledge are critical. Working knowledge of good quality management systems including CAPA management, document control and Good Documentation Practice (GDP). Attention to detail. Strong organizational skills. Ability to organize own workload according to priorities set by the Global Medical Device Quality Manager. Ability to adapt quickly and show flexibility. Teamwork skills. Ability to write clear procedures. Familiarity with the most important MS Office tools (Word, Excel, Outlook). Fluent in spoken and written English. ideal. Learn more about the global medical device regulations MDR and IVDR and the Medical Device Directive MDD. Knowledge of certification standards ISO ⚠.⚠:⚠, ISO ⚠, ISO ⚠

Experience Required:

• Extensive professional experience in a position responsible for quality assurance

Desirable:

• Experience handling medical devices
• Experience testing according to recognized standards

Qualifications Required:

• Bachelor's degree (or higher) Biomedical Sciences or similar fields (e.g. Pharmacy, Bioengineering, Nursing...)

Ideal:

• MDD, MDR, IVDR or ISO ⚠ Medical Device Auditor training

We look forward to hearing from you! Use the Apply button to send us your story and resume, and maybe you'll join us soon. For more information, please email @.