)
)
Quality Management / QA Consultant – IVDR & ISO 15189
Responsibilities:
Provide expert advice and support in the implementation of regulatory requirements relating to IVDR and ISO 15189
Assess the existing Quality Management System (QMS) against IVDR requirements and identify potential gaps and areas for improvement
Advise on the strategic and structural development of the QMS in line with the company's increasing focus on pharmaceutical clients
Support the definition and implementation of appropriate quality processes and measures
Provide external technical guidance and review of the planned GCP project, particularly regarding the project strategy, project plan and defined milestones (gates)
Contribute best practices from regulated laboratory and diagnostics environments
Provide ad hoc support and knowledge transfer to the existing Quality Management team
Qualifications:
Several years of professional experience in Quality Management / Quality Assurance within a regulated environment
Strong expertise in IVDR, ideally combined with practical experience in its implementation within laboratory or diagnostics environments
Good knowledge of ISO 15189 and its requirements for medical laboratories
Experience in advising on and further developing Quality Management Systems
Understanding of GxP and GCP requirements and their interfaces with laboratory processes
Experience in interpreting regulatory requirements and translating them into practical measures within existing quality structures
Experience as an external consultant or interim expert is an advantage
Excellent English skills; German language skills and/or a DACH background are desirable but not mandatory
Independent, structured and solution-oriented working style, with the ability to act as an ad hoc sparring partner for the existing Quality Management team
Project Details:
Start: 2027
Duration: Ad hoc support as part of a broader project running until the end of 2028
Weekly Hours: Flexible part-time arrangement depending on requirements; initially, approximately 40 hours are planned for IVDR consulting
Location: Austria, fully remote possible
)