Quality Engineer/Specialist

For Quality services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or related field and at least four (4) years of previous exposure to Audit Observations, Investigations & CAPA activities within the regulated industry.
• Bilingual: (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • NC/CAPA & Audit Observations process 
  • FDA 21 CFR and global medical device regulations and standards
  • 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)

• Initiate NRs as required.
• Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
• Plan and execute product disposition.
• Plan and execute actions related to NC/CAPA & Audit Observations.
• Close the investigations and Product Dispositions on time.
• Identifies and escalates to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
• Reviews and analyzes quality trends with the manufacturing team.
• Considering quality trends provides direction in setting work priorities for process enhancement.
• Provides leadership and guidance to cross-functional, multilevel technical teams to ensure that causes of non-conformance are identified and understood, and that sound corrective/preventive actions are implemented.
• Evaluation of the implemented corrective and preventive actions against trends to assess the effectiveness of the same.
• Leads investigations of the negative trends and, in alignment with the Process Engineer and the Manufacturing Manager, facilitates the implementation process.
• Analysis of data and based on the trends recommends actions for process, equipment, and system improvement.

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?