Quality Engineer/Specialist

Flexible & Integrated Technical Services

  • Añasco, PR
  • Permanente
  • Tiempo completo
  • Hace 1 día
  • Postúlese fácilmente
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 escalate to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
  • Reviews and analyses quality trends with the manufacturing team.
  • Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
  • Provides leadership and guidance to cross functional, multilevel technical teams to assure 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 effectiveness of the same.
  • Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities 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?Powered by JazzHR

Flexible & Integrated Technical Services