Overview

We are supporting an innovative Diagnostics business in East Germany that is seeking a highly skilled Freelance Quality Management Consultant to strengthen its quality systems during a critical phase of development. This role will suit an experienced professional who thrives in hands-on environments where their expertise directly shapes compliance, regulatory readiness, and operational excellence.

Key Responsibilities

Lead and manage the company’s Quality Management (QM) system in alignment with ISO 13485 and IVDR requirements.
Review, maintain, and update documentation to ensure full regulatory compliance.
Support internal and external audits, addressing findings with effective CAPAs.
Collaborate with R&D, Manufacturing, and Regulatory Affairs to embed quality across the business.
Provide training, guidance, and best practice insights to internal teams.

Candidate Profile

Proven track record in Quality Management within IVD / Diagnostics (ISO 13485 essential).
Strong understanding of IVDR requirements and their practical application.
Hands-on, detail-oriented, and capable of quickly identifying gaps and implementing solutions.
Comfortable working in a freelance/interim capacity and delivering impact from day one.
Based in Germany and able to travel as needed to office in East Germany.

If you are a freelance Quality Management Consultant with diagnostics/IVDR experience and are interested in supporting this project, please apply via LinkedIn or contact me directly for a confidential discussion.

Job Details

Seniority level: Director
Employment type: Contract
Job function: Project Management
Industries: Medical Equipment Manufacturing

References to referrals and other roles are provided as part of the recruitment process.

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