Product Risk Manager (m/w) – beendet

  • Position zu besetzen ab 1. Februar 2018
  • Permanent-ID OCR-FL-2018-1010
  • Branche Medizintechnik
  • Beschäftigungsform Freelance/ Contracting
  • Standort 7x
  • Kategorien Freelance/Contracting, Medizintechnik

Anforderungen
• Successfully completed Master de-gree in Engineering, preferred Computer Science, Mechanical or Electronical Engineering
• Minimum 3 years directly related working experience, preferably within the regulated industry (e.g., medical devices, aerospace, or similar)
• Knowledge of FDA Regulatories as well as ISO-13485, DIN EN ISO 14971, 21CFR Part 11
• Fluent English language skills to work in an international environ-ment

Aufgaben:
• You are a member of the risk man-agement team during the develop-ment and the post launch period of our laboratory automation products
• You are responsible for the ongoing risk management process and the re-sulting upgrade of the Risk Manage-ment File (maintain RMF and PRA) from postlaunch period until end of the product life cycle
• You are accountable for risk analysis, risk evaluation was well as risk control
• You verify the effectiveness of risk control
• You escalate relevant risks from D-FMEA and input from P-FMEA to PRA

Zusätzliche Informationen:
Standort: GR Stuttgart
Projektbeginn: 01.02.2018
Projektlaufzeit: 31.07.2018
Verfügbarkeit: Vollzeit vor Ort
(voraussichtlich 960 Stunden)

 

OCR-FL-2018-1010 Product Risk Manager

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