Quality Engineer

For Quality Assurance services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering and a minimum of three (3) years of exposure in Quality activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish) 
• Shift: Administrative & according to business needs
• Experience in:
  • Validation Life Cycle 
  • Change Control 
  • Documentation
  • 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)

• Review and approve changes in procedures and validations from a Quality Assurance perspective.
• Support Quality Improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Support the development of quality engineering and quality compliance roles with the right skill sets for existing processes and product life cycle management.
• Support investigations, bounding, impact evaluations, review and approval of NRs, CAPAs and customer complaints and escalates quality issues as appropriate.
• Identify Manufacturing process defects by disposition of nonconforming material, identifying primary root causes and suggesting corrective and preventive actions.
• Provide support to business functions on procedural readiness execution and remediation, measuring execution and effectiveness as required.
• Provide support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
• Generate test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.

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?