Quality Audit & Risk Manager

Remote Arbeitsplatz Tasks: Review and improve current quality processes for digital and hardware products.

Develop and implement a comprehensive QMS for both digital solutions and hardware (e.g., 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 Reference CR/122935_1734014760 Wir suchen für unseren Kunden einen erfahrenen SAP PP/PPPI/QM und PM Support-Berater, der uns mit...