Quality Engineer

For Quality services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least five (5) years of exposure to Quality Engineering activities within the Pharmaceutical or Medical Devices industry. ,
• ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA).​​​​(preferred) 
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Quality System Regulations (QSR), ISO standards, Design Control, and Process Validation guidelines. 
  • ISO cleanrooms 
  • Cleaning Methods and Cleaning Validation 
  • Statistical Techniques: SPC, DOE, Process Capability, and Gage R&R. 

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 technical documentation such as: Validation Protocols, Technical/investigation reports, Standard Operating Procedures (SOPs), Validation Plans, and Change Controls. 
• Implement and support quality programs including: Tracking, Analyzing, Reporting, and Problem-solving. 
• Support or conduct internal and external audits, including planning, execution, and follow-up.
• Plan, control, and assure product and process quality using key quality principles
• Apply standard quantitative methods for data collection and analysis to drive improvements.
• Apply strong project management skills to coordinate efforts.
• Collaborate cross-functionally across departments.
• Contribute as a team player and self-starter.

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?