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Quality Engineer

Arroyo, PR
DESCRIPTION

The Quality Engineer will provide support to Projects and New Product Introduction. Must be able to perform Validation/Qualification such as but not limited to all Components and End Items. The resource must possess strong knowledge in Statistical Process Control and be able to review/perform validation protocols (IQ, OQ, PQ).
  
EDUCATION
Bachelor Degree in Engineering and minimum of 4 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry.


REQUIREMENTS
 
  • Provide support and approval for all documentation required for project deliverable
  • Plan, write, coordinate, execute, summarize, review validation protocols, transfer plan validation, risk assessments
  • FAT, SAT, Commissioning, CSV, IQ, OQ, PQ
  • Deviations, results and approvals for Equipment and Tooling
  • Minitab
  • Problem Solver
  • Fully Bilingual (verbal and written) 

 

Ultimate Solutions Corp is an Equal Opportunity Employer

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