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Advance Quality Engineer

Arroyo, PR
DESCRIPTION
The Quality Engineer will provide support to Projects. Must be able to perform Test Methods for Incoming Inspection, Final Release Test Method Validation/Qualification such as but not limited to all Components and End Items. In addition knowledge in Statistical Process Control and be able to review/perform validations (IQ, OQ, PQ).

 
EDUCATION
Bachelor Degree in Science or Engineering and minimum of 5 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry.



REQUIREMENTS
  • Experience working with Test Methods for Incoming Inspection
  • Test Method Validation/Qualification
  • Risk Assessment 
  • ​Support and approve all documentation required for project deliverable
  • Plan, write, coordinate, execute, summarize, review validation protocols, transfer plan validation
  • FAT, SAT, Commissioning, CSV, IQ, OQ, PQ, Deviations, results and approvals for Equipment and Tooling.
  • Set-up of Incoming Inspection equipment, ensure satisfactory operation and train on inspections
  • Generate new MP’S, IP’s, TM’s and obtain approvals
  

 

Ultimate Solutions Corp is an Equal Opportunity Employer

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