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Quality Engineer

Jornada completa

Flexible & Integrated Technical Services, LLC

  For Remediation services in the Quality Assurance area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and 5 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 the business
  • Experience:
    • Quality assurance focused on reviewing validation cycle documentation, quality systems, procedures, change control, and design control.

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)

  • Quality processes, including change assessments, process validations, and software validations, as well as experience in sterile packaging and labeling systems.
  • Conduct and manage change assessments and process validations to ensure compliance with regulatory standards and company policies.
  • Perform ESQ (Engineering Software Quality) and software validations to maintain high-quality software performance and reliability.
  • Oversee sterile packaging processes, including final packing and labeling, ensuring adherence to safety and quality standards.
  • Conduct inspections of labeling systems and processes to guarantee accuracy and compliance.
  • Collaborate with cross-functional teams to identify and address quality issues, implementing corrective actions as needed.
  • Utilize and maintain knowledge of systems such as Windchill, CAPA, MES, and BMRAM for effective quality management and documentation.
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?

Vacante publicada el Hace 2 meses
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