Product Quality Assurance Officer – English – Utrecht

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Beatrice Bancheri
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Responsibilities/Tasks

The Product Quality Assurance (QA) Officer is responsible to ensure quality compliance in all company projects, and that all product- and manufacturer-related documentation align with the quality requirements set forth in the relevant policies. The QA Officer also supports the QA and Regulatory (QA&R) Manager and works closely with multiple units across the company.

  • Provide inputs on the product prequalification process with the assistance of the QA&R Responsible Pharmacist and manage product dossiers or other technical documentation.
  • Compile product dossiers on diagnostic devices and food intended for medical proposes; keep the dossiers up to date with latest technical documentation/certificates, ensuring proper filing of records related to QA decisions during the product management lifecycle; and ensure accuracy of dossiers received from vendors, working with Product Technical, Product Information Management, Sourcing & Supplier Contracts and Supplier Engagement, Client Services, Logistics
  • Monitor field safety-notices (FSN) and -corrective actions (FSCA) issued by manufacturers, published by regulatory authorities or available on ECRI platform, and liaise with suppliers and internal units to collect additional information and resolve potential safety issues.
  • Assist the QA&R Responsible Pharmacist to populate the knowledge management repository for product quality-related guidelines and legislation for different product categories.
  • Record and update the non-pharmaceutical suppliers QA documentation related to (re)approval and QA information in the SRM tool. Assist the SRM content team in the improvement of the SRM tool.
  • Maintain the item master to ensure that only approved products are procured and supplied, in line with defined QA policy; and work with IT to implement necessary corrective actions to data management systems and to improve QA related features in the ERP system.
  • Contribute to the development and the design of the IT system for collection of product information and ensure QA compliance working with the Product Information Management Unit.
  • Support Client Services and Sourcing & Supplier Contracts Units in defining product eligibility and quality requirements of medical devices and in-vitro diagnostic devices in collaboration with the QA Unit.
  • Support QA-related incidents by gathering information and support QMU on preparing reports on incidents.
  • Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions.
  • 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 working with the QA&R Responsible Pharmacist.
  • Collaborate with Product Technical, Product Information Management, Sourcing & Supplier Contracts and Supplier Engagement and QA &R Units to streamline catalog management by contributing insights from medical devices and in-vitro diagnostic regulations.
  • Assist in collection of correspondence and documentation of suppliers’ quality auditing process, working with the QA& R Manager.

Requirements

Professional and Technical Knowledge

  • 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- and 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, and specifically of essential diagnostics required for COVID-19, HIV/AIDS, Tuberculosis, and Malaria.
  • Ability to work comfortably with Microsoft Office software, preferably advanced user level of Excel.
  • Willingness and availability to travel, and perform other duties as needed.

Interpersonal skills/Communication

  • Excellent written/verbal communication skills, English fluency required.
  • Strong interpersonal skills with client relations and customer service experience and an ability to work across disciplines and locations.
  • Demonstrated analytical skills; solution oriented with a high sense of quality, attention to detail, accuracy, efficiency, and meeting tight deadlines.

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