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Quality System Expert - Medical Devices
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Engineering, Design
Projektbeschreibung
QUALITY SYSTEM EXPERT - MEDICAL DEVICES, 5 MONTHS CONTRACT
Main Task:
WORK WITH CROSS-FUNCTIONAL TEAM TO ENSURE DOCUMENTATION IS COMPLIANT TO REGULATIONS AND QMS FOR COMBINATION PRODUCTS FOR THE US AND EU MARKETS.
SUPPORTING PROJECT LEADERS TO DEVELOP PROJECT DEVICE PLAN AND AUTHOR DELIVERABLES MATRIX AND DHF CONTENT LIST.
Work with team to resolve any design process related issues concerning documentation.
REQUIRED EXPERIENCE:
SENIOR EXPERT IN MEDICAL DEVICE DEVELOPMENT AND COMBINATION PRODUCT WITH MINIMUM 5 YEARS EXPERIENCE.
EXPERIENCE IN DEVICE DEVELOPMENT FOR US AND EU MARKETS.
Experience with syringes, auto injectors, pen injectors as well as auditing experience is a plus.
EDUCATION:
Minimum Bachler degree in Science/Engineering or Mechanical Engineering or University level Engineering education is preferred.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Main Task:
WORK WITH CROSS-FUNCTIONAL TEAM TO ENSURE DOCUMENTATION IS COMPLIANT TO REGULATIONS AND QMS FOR COMBINATION PRODUCTS FOR THE US AND EU MARKETS.
SUPPORTING PROJECT LEADERS TO DEVELOP PROJECT DEVICE PLAN AND AUTHOR DELIVERABLES MATRIX AND DHF CONTENT LIST.
Work with team to resolve any design process related issues concerning documentation.
REQUIRED EXPERIENCE:
SENIOR EXPERT IN MEDICAL DEVICE DEVELOPMENT AND COMBINATION PRODUCT WITH MINIMUM 5 YEARS EXPERIENCE.
EXPERIENCE IN DEVICE DEVELOPMENT FOR US AND EU MARKETS.
Experience with syringes, auto injectors, pen injectors as well as auditing experience is a plus.
EDUCATION:
Minimum Bachler degree in Science/Engineering or Mechanical Engineering or University level Engineering education is preferred.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik