QA Engineer

Añasco, Puerto Rico
Contracted
Medical Device
Mid Level

For Quality services in the Facilities area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Life Sciences, Engineering, or related field and at least three (3) years of previous exposure to Quality Engineering activities within the regulated industry.
  • Bilingual: (Spanish and English)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • QA Review
    • GMP & GDP regulations

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 take on this new challenge?

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

  • Support the implementation of effective quality assurance processes for new facility systems, processes, and technologies.
  • Provide support for the validation and certification of facility systems, equipment, utilities, and software as required.
  • Generate test protocols, monitor testing, issue qualification test reports, and approve qualification plans/reports for facility-related systems and processes.
  • Provide support for activities, documents, and records requiring QA review and/or approval as necessary.
  • Alert the organization to issues in a timely manner to prevent potential negative impacts on customer satisfaction, company image, or business reputation.
  • Collaborate with multi-functional teams to establish project plans and ensure continuous support for new facility projects, while maintaining ongoing operations.
  • Develop standard operating procedures, specifications, and provide technical transfer and validation support for facility systems.
  • Utilize appropriate risk management tools to prevent unanticipated failures and enhance the capability and reliability of facility processes. 

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?

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