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Quality Assurance Manager

Cambridge, MA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
  • Project management skills
  • Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
  • Experience with quality records
  • Experience with physical method validation, qualification and transfers

Day to Day Responsibilities:            
  • Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs
  • Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods
  • Review and approve physical test method design documents, validation, qualification and transfer documents
  • Review and approve quality records (deviations, CAPA/EVs, change controls)
  • Lead problem solving and lean improvement projects

"This posting is for Contingent Worker, not an FTE"


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