Quality Engineer

Full Time
Dorado, PR 00646
Posted
Job description

For Quality services in the Validation area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s Degree in Engineering or science and five (5) years of exposure in Process Validation, Quality and Validation life cycle within the Medical Device or Pharmaceutical industry.
  • Bilingual English/Spanish, both written and verbal
  • Shift: Administrative and according to business needs. Flexibility to work extended hours (can take work Saturday or Sunday)
  • Experience in:
    • Process validation.
    • Medical Device documentation.
    • Process development and good technical knowledge.
    • Quality Systems and good documentation skills.

The Personality Part:

  • If you feel a passion for transforming lives and innovating with new medical solutions, using global collaboration, high performance, diversity and winning spirit, then this is a job for you.

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

  • Responsible for the review and approval of validation and qualification protocols specifically software validations.
  • Interacts with several functional departments including; IT, Manufacturing, Quality Follow procedures, specifications, and standards for the site.
  • Ensure processes and procedures follow regulations.
  • Customer focus and able to work under minimal supervision.
  • Working alone or with little direction.
  • Support investigation task items, CAPA’s Change Controls and trend evaluation.
  • Provide documentation and timely resolution of exception documents based on CAPA requirements.
  • Participate in site meetings to ensure timely identification and management of site events.
  • Perform Track and Trend of investigations to identify quality issues trend.

BEING A FITS PIECE COMES WITH PERKS:

  • One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

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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