Quality Systems Specialist- 143

For Validation services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Science or Engineering and (2) two years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent leader skills
• Shift: Administrative, and according to business needs. 
• Experience in: 
  • Test Method Validation (IQ/PD/OQ/PQ) and CSV
  • Manufacturing documentation changes
  • Equipment Validation 
  • Equipment relocation and Incoming inspection. 

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)

• Supports equipment and test method validation and supporting documentation as an author or quality reviewer.  
• Supports process documentation changes as author or quality reviewer.
• Provides oversight of quality processes and procedures that ensure compliance with policies and the performance and quality of services.  
• Guides in interpreting policies, regulatory regulations, and agency guidelines to ensure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Delivers projects assigned and works with other stakeholders to achieve desired results.
• The majority of time is spent delivering the projects while adhering to policies, using specialized knowledge. 

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?