Quality Engineer

FITS LLC · Other US Location

Company

FITS LLC

Location

Other US Location

Type

Full Time

Job Description

For Quality Engineering services in the Manufacturing and Engineering areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and previous exposure to Quality Engineering activities within the Pharmaceutical or Medical Devices industry. 
  • Bilingual (Spanish and English)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • GMP & GDP regulations

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)

  • Develop and implement quality control processes for medical devices and products.
  • Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.
  • Lead internal audits and prepare for external regulatory inspections (FDA, ISO, etc.).
  • Analyze quality data to identify trends and implement corrective actions.
  • Collaborate with cross-functional teams to resolve quality issues and improve product performance.
  • Ensure compliance with FDA regulations, ISO standards, and other applicable quality requirements.
  • Participate in design reviews and validation activities for new product development.
  • Manage and maintain quality management system documentation.
  • Train staff on quality procedures and best practices.
  • Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.

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?

Apply Now

Date Posted

09/03/2024

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