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Supplier Quality Engineer

Arroyo, PR
SUPPLIER QUALITY ENGINEER

Description


Seeking a Supplier Quality Engineer with experience in the pharmaceutical and medical devices industries. The candidate must have solid GMP and regulatory experience.

Duties & Responsibilities
  • The Supplier Quality Engineer will spent more than half of the time in MSA and PPAPs.
  • The Supplier Quality Engineer will be responsible of Attribute Charts/Incoming Inspection Procedures, Component Failure Mode & Effects Analysis (CFMEA), Engineering Prints, Gage R&R validations, Minitab Assessment, Non Conformance Documentation, Quality Inspection Procedures (QIP), Sterilization Validation, Supplier Validation – Component Qualification, Work Instructions (TI’s or PPM).
  • The Supplier Quality Engineer will support Equipment Qualification, Fixture / Equipment Prints, Packaging Validation (including Sealing Validation), Process Characterization, Process Failure Mode & Effects Analysis (PFMEA), Process Validation (PC, Test Method, OQ-P, Overall Process Validation), other tasks may be assigned. 
Skills and Specifications
  • Quality Assurance experience
  • Read and interpret prints 
  • GD&T knowledge highly desirable
  • Minitab
  • Validation experience
  • Bilingual (English & Spanish)
Experience

3+years of experience in a similar or related role

Education

Bachelor in Engineering (BSME, BSEE, BSChE, BSIE preferred) 

Additional Requirements
  • Problem Solving 
  • Sense of urgency 
  • Detail Oriented 
  • Be flexible enough to travel to job sites when need arises. 
  • Willing to work overtime including weekend depending ion the nature of work available. 
  • Able to work with minimum or no supervision 
  • Strong interpersonal skills and must work in a team 

Ultimate Solutions Corp is an equal opportunity employer.
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