Quality Engineer

For Quality Engineering services in the Quality area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least (5+) years of experience performing quality engineering functions within a manufacturing environment.
• Bilingual: (Spanish and English). 
• Soft Skills: Problem-solving, excellent time management, and good decision-making. 
• Lean Six Sigma certification preferred.
• Shift: Administrative and according to business needs. 
• Experience in:
  
  • Medical device industry
  • Write technical reports and documents
  • Microsoft Excel data migration
  • Developing and reviewing pFMEA documents

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Provide guidance and support for Excel data migration from current Process Risk Assessment documents to a new Excel process Failure Mode and Effect Analysis (pFMEA’s) format.
• Must be able to interpret/ understand process Failure Mode and Effect Analysis (pFMEA’s) - Global Work Instruction.
• Providing technical expertise and support for process Failure Mode and Effect Analysis (pFMEA’s) assessments for Juana Diaz (PRMO/ PRPO) manufacturing site in-line and other support processes.
• Must be able to evaluate multiple systems (Incoming, Receiving, Infrastructure, Formulation (Monomer & Solution) Laboratories, Dry & Wet Lens Manufacturing Processes, Sterilization, Packaging, etc.) to generate and or review pFMEAs and identify existing or potential gaps.
• Must be able to Identify and evaluate process Failure Mode and Effect Analysis (pFMEA’s) enhancements.
• Good understanding of GMP, GDP, and GLP guidelines.
• As needed, provides support for ongoing compliance initiatives, assessments, remediation/ corrective actions, and training.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?