Quality Systems

For Quality services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and at least three (3) years of previous exposure to Quality System activities within the regulated industry.
• Bilingual: (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • General knowledge of quality system requirements, including familiarity with US FDA 21 CFR Part 820 and ISO13485 requirements.
  • Use of applications/systems which support our quality system, such as document management system, change control, nonconformance, CAPA, audit, metrics reporting systems, etc.
  • Ability to work independently and/or collaboratively in order to complete work assignments and tasks.
  • Manage time, assignments, projects, and tasks in a methodical manner to ensure scheduled and planned deliverables are completed on-time and accurately.
  • Basic project management and project leadership abilities.

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)

• Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.
• Monitors and tracks all sources of quality detractors utilizing various sources as systems and records.
• Manages all changes types in the document management system.
• Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations. Develops solutions to database problems of moderate scope and complexity.
• Coordinates and participates in the approval process of the changes.
• Writes and assists others in writing standard operating procedures.
• Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams.
• Provides support to product review and release functions.
• Generates moderately complex statistical summaries. Uses quality tools and computer generated reports to continuously improve process capabilities.
• Perform investigations associated to the Quality Systems.

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?