Do you have experience in quality assurance in medical device & diagnostics or pharma industry?
Do you feel deeply motivated at the right job when your role best fits your aspirations and values? If so, then read on!
Our client is a leading supply chain company aiming to offer innovative approaches to improve health and wellbeing around the world!
They’re looking to hire a Product Quality Assurance Officer to support them and share the organization’s values.
- Manage and maintain product dossiers or technical documentation submitted as part of client’s product prequalification process.
- Support operational units in defining product eligibility and quality requirements and corresponding QA documentation, specifically for medical devices and diagnostics.
- Liaise with Strategic Supply Chain and Client Service Units to ensure completeness and accuracy of product dossiers received from vendors, as part of RFQ/RFP process.
- Compile and complete initial screening of product dossiers to make any required recommendations for their approval to the QA and Regulatory Manager.
- Ensure proper filing, access, and retrieval of product dossiers and records related to QA decisions.
- Track the Global Fund’s eligible list of diagnostics on a weekly basis and coordinate with the Product QA Data Officer to ensure that only approved products are maintained in client’s item master in the ERP system.
- Centralize product QA requirements in a relevant tool/platform to serve as a quick reference for operational units.
- Collaborate with Strategic Sourcing to streamline catalogue management by contributing insights from medical devices and diagnostics regulations.
- Monitor field safety notices (FSN) and field safety corrective actions (FSCA) issued by manufacturers and liaise with suppliers and internal units to ensure required actions are completed.
- Support Logistics and 4PL Units in shipment planning and ensuring compliance with local regulatory requirements by providing insights on product characteristics, stability profile and storage requirements.
- Summarize and verify shipment/data logger reports under the supervision of the QA and Regulatory Manager, notify Logistics Unit on the disposition of the delivered goods.
- Support QA-related incidents by gathering information, providing input for investigation and contributing to the resolution.
- Support QMU by preparing reports on incidents that communicate status, trends and outstanding actions for management review, project management, and KPI reporting to the client.
- Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions in line with client’s Quality Management System.
- Bachelor’s degree in Healthcare and Life Sciences or other relevant field.
- 3+ years’ work experience in quality assurance/regulatory affairs in a medical device & diagnostics industry, healthcare organization.
- Knowledge about Good Manufacturing Practices, Good Distribution Practices, ISO 13485, and other relevant standards.
- Understanding of the medical device & diagnostics regulatory environment both at international and country level.
- Knowledge of the international health products market with specific reference to essential diagnostics required for COVID-19, HIV/AIDS, Tuberculosis, and Malaria.
- Strong interpersonal skills and an ability to work across disciplines and in diverse locations internationally.
- Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint. Advanced user level of Excel preferred.
- Excellent written/verbal communication and interpersonal skills with strong sense of customer service. English fluency required, including speaking, writing, understanding, and reading.
- Demonstrated analytical skills; solution oriented with a high sense of quality, attention to detail, accuracy, efficiency, and meeting tight deadlines.
- Team player who is also able to work independently and handle conflicting priorities while maintaining consistent, quality performance standards.
- Willingness and availability to travel, and perform other duties as needed.
- Must be authorized to work in the Netherlands.