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Quality Engineer

Quality Engineer

FITS, LLCDorado, PR, US
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Overview

For Remediation services in the Quality Assurance area.

What makes you a fit

The Technical Part :

  • Bachelor's Degree in Engineering and 3 - 4 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
  • Bilingual : Spanish and English
  • Soft Skills : Attention to detail, organization, and writing skills.
  • Shift : Administrative, and according to business
  • Experience :
  • Validation Master Plans
  • Standard Operating Procedures (SOPs)
  • Change Controls
  • Protocols
  • User Requirements Specifications (URS)

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?

    • Role responsibilities

  • Responsible for the review and approval of validation and qualification protocols, specifically software validations
  • Interacts with several functional departments, including IT, Manufacturing, and Quality.
  • Follow procedures, specifications, and standards for the site
  • Ensure that process development and procedures comply with regulations
  • Customer-focused and able to work under minimal supervision
  • Generate and execute Process Validation based on equipment capabilities
  • Support investigation task items, CAPAs, 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 trends

    • Who we are

    We are a Service Provider company different from the rest. We pride ourselves on 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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We\'re FITS! Are you the next piece?

    Seniority level

  • Mid-Senior level

    • Employment type

  • Contract

    • Job function

  • Quality Assurance
  • Industries
  • Internet Publishing

    • Referrals increase your chances of interviewing at FITS, LLC by 2x

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    Quality Engineer • Dorado, PR, US