Beschreibung
Tasks• Review and compilation of Design History Files to ensure
compliance of combination devices regarding the 21 CFR Part 820
• Performing risk management analysis/ FMEA´s according to the ISO 14971 incl. human factors
• Draft test protocol regarding the combination devices regarding stability & sterilization
• Developing traceability matrix regarding design Input & Output
Qualification
• Solid experience with combination devices and the FDA 21CFR part 820 regulation
• Very good knowledge of risk management/ FMEA´s acc. to the ISO 14971
• Good Experience regarding DHF remediation projects and Design Control
• Very good English skills, German is a plus
• Teamoriented and hands-on personality