QA / IVDR Consultant

K-Recruiting GmbH; Austria; Remote; EUR 83,000 - 131,000; Full time

Job summary

K-Recruiting GmbH is seeking a Quality Management / QA Consultant to advise on IVDR and ISO 15189 compliance in a laboratory/diagnostics setting. The role focuses on assessing the QMS, identifying gaps, and shaping strategic development aligned with expanding pharmaceutical clients.

You will provide external guidance for GCP project planning, share best practices from regulated environments, and transfer knowledge to the internal Quality Management team.

Qualifications

• Several years of professional experience in Quality Management within a regulated environment.
• Strong IVDR expertise with practical implementation in laboratory or diagnostics environments.
• Good knowledge of ISO 15189 and its requirements for medical laboratories.
• Experience advising on and developing Quality Management Systems.
• Understanding of GxP and GCP requirements and their interfaces with laboratory processes.
• 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.

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.

Skills

Quality management

IVDR expertise

GxP/GCP knowledge

Quality systems advisory

English proficiency

Job description

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