Sr. Quality Application Specialist - 142

For validation services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and (4) four years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent Team leader skills
• Shift: Administrative, and according to business needs. 
• Experience in: 
  • Test Method Validation (IQ/PD/OQ/PQ) and CSV
  • Documentation changes
  • Equipment Validation 
  • Quality and Compliance 

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 of 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 Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation. 
• Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods.
• Experience in the identification, implementation, and maintenance of the procedures, actions,s and documentation necessary to assure compliance. 
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems. 

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 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?