Quality Audit & Risk Manager - 6months + - Remote - Start January

Our client is looking for a Quality Audit & Risk Manager for developing a platform to create digital twins of physical objects for authentication across various industries. Your main task is to establish a Quality Management System (QMS) for both digital and hardware components, ensuring the highest quality standards and compliance.

Tasks:
Review and improve current quality processes for digital and hardware products.
Develop and implement a comprehensive QMS for both digital solutions and hardware (eg, hand-held reader devices).
Evaluate GxP and 21 CFR Part 11 compliance needs.
Write and implement Standard Operating Procedures (SOPs).
Lead audits and risk assessments, providing solutions to mitigate risks.

Requirements:
5+ years of experience in quality management, auditing, or risk management for digital and hardware products.
Strong knowledge of GxP, 21 CFR Part 11, and ISO 27001.
Experience in drafting and implementing SOPs and audit preparation.

Project Details:
Start: January
Duration: 6 months (+ option to extend)
Workload: 5 days per week
Location: Remote (1-2 times onsite for important meetings in Germany)
Languages: Fluency in English (German nice to have)

Telephone interview slots with our client can be arranged at short notice with a decision immediately thereafter