Quality Engineer

 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?

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, 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, 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 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?