The companyOur client is a professional Medical Devices organization, based in Zuid-Holland Netherlands. Our client is a commercial-stage biotech company. They specialize in the development and marketing of innovative gene signature based diagnostic tests to assist healthcare professionals in making personalized treatment decisions for individual patients.
Role descriptionYou will be responsible for the support for a very wide variety of QA/RA related tasks to ensure that all of the company’s activities are performed at the appropriate quality level. Amongst others you will improve and maintain the quality system according to the ISO-13485, ISO-15189 and FDA 21CRF820 Quality system regulations. You will be managing during writing and executing Quality related procedures and plans with the QA/RA Officer. Reviewing design and development related documents like procedures, technical file documents, and validation documents. You will be managing, organizing and executing internal and external audits. Organizing and providing quality related trainings. Reviewing analytical data for diagnostic services, incoming goods QC and batch release purposes. Managing change control, document control, deviation and non-conformance handling.
Responsibilities- CE Marking/510(k) Approval
- Provide leadership and guidance on the Quality Management System and measures its effectiveness in meeting the requirements of ISO 13485 and ISO 9001
- Provide support to operations and closely interact and build effective relationships with all functional groups to promote quality, consistency and compliance
- Overall management and maintenance of document control and support international document control requirements and provides input and review of all quality systems documents
- Manages all aspects of the quality systems such as CAPA, Complaints and Deviations and drives improvement
- Supports activities relating to Field Actions as required and maintain regulatory documents
- Contribute to local and global meetings by providing and sharing quality information
- Follows up corrective and preventive actions as necessary and is actively involved in problem solving to ensure timely and accurate resolution of problems identified
Requirements- Bachelor or Master Degree in life science related topic
- Demonstrated experience (> 5 years) as a QA officer in a medical device or in-vitro diagnostic device company.
- Experienced in writing and reviewing quality, and design and development related documents.
- Experience in quality planning, auditing, hosting audits and inspections.
- Experience in deviation, non-conformance, CAPA and change control handling
- Experience with quality evaluation of laboratory test results
- Demonstrated experience with successfully implementing relevant quality system regulatory requirements with respect to at least GMP, 21 CRF 820,
medical devices (ISO-13485)
- Familiar with directive 98/79/EC for in vitro diagnostic medical devices
- Familiar with FDA guidance documents in relation to in-vitro diagnostic product development
- Additional experience with implementing quality system regulatory requirements with respect to and - or diagnostic laboratories (ISO-15189) is a pre.
- Experience in writing CE registration files and IVD submission files for FDA 510(k) clearance or pre-market approval is a strong pre