FDA QMSR Readiness: Risk Management Process Assessment and Optimization

Project overview

Your area of responsibility

What you bring

Contact person: Junior Talent Acquisition Specialist Ms. Melina Braun

FERCHAU GmbH

Wiesbaden Pharma & Life Science Branch

Alte Schmelze 18-20

65201 Wiesbaden

• Review and assessment of the existing risk management process, including documentation at pilot sites
• Identification and prioritization of compliance, methodology, and governance gaps with regard to FDA QMSR requirements
• Development of consolidated recommendations for improving the risk management methodology, including FMEA linkage, IT tool configuration, and risk-based statistical methods
• Application of the optimized methodology to two pilot projects (single-use and active medical devices), including coaching of the implementation
• Creation of a management presentation with action recommendations, findings from the pilots, and a roadmap for internal scaling
• In-depth knowledge in the field of risk management for medical devices according to FDA requirements (QMSR)
• Experience with Hazard Analysis, Design FMEA, Application FMEA, Software FMEA, and Process FMEA, as well as their integration in the product lifecycle
• Knowledge in the configuration of IT tools for risk management process management
• Experience in applying risk-based statistical methods in risk analyses of medical products
• Ability to conduct gap assessments and develop actionable optimization measures in the regulatory environment

Project details

• Start: 2026-11-02
• Remote: remote
• Location: Bad Homburg, Deutschland, DE
• Languages: German