Freelance Quality Management Consultant – Diagnostics

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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