Quality System Analyst

Añasco, Puerto Rico
Contracted
Medical Device
Mid Level

For Quality services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Science or Engineering and at least five (5) years of previous exposure to Quality activities within the regulated industry.
  • Bilingual: (Spanish and English)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • Quality system requirements including familiarity with US FDA 21 CFR Part 820 and ISO 13485 regulations. 
    • Use of applications/systems that support our quality system such as document management system, change control, non-conformance, CAPA, audit, metrics reporting systems, etc.

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)

  • Monitors and tracks all sources of quality detractors utilizing various sources as systems and records.
  • 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.
  • 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 advanced technical assistance in the use of information mapping technology.
  • 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.
  • Provides support to good manufacturing practice auditing and site readiness activities.
  • Provides supports collecting inputs for the management review and data review boards.
  • Verifies that quality systems are effectively deployed.
  • Performs periodic routine checks to verify appropriate application.

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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