Quality Engineer II- 090

For engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and two (2) years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Good problem-solving skills
• Certifications: Lean Six Sigma Green Belt 
• Shift: 1st and according to business needs. 
• Experience in: 
  • Non-Conformance CAPA and Investigations. 
  • Identifying and Implementing Corrective/Preventive Actions.
  • GMP regulations. 
  • Microsoft Office (Excel, Word, Outlook, PowerPoint, Project), Agile, Maximo, MRO Program, SAP, Agile, and Compliance Wire.

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)

• Conducts a compliant validation process for quality information technology systems, requiring formal documentation (including SOP).
• Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods.
• Identifying, implementing, and maintaining the procedures, actions, and documentation necessary to assure compliance. 
• Reports on the status of validation activities to fulfill regulatory requirements.
• Performs system administration and configuration of quality information technology systems.
• Performs investigation of non-conformance events. 
• Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures.
• Verifies the implementation and effectiveness of non-conforming CAPA.
• Executes job responsibilities as established in the procedures.
• Evaluating, Investigating & Completion of Non-Conformance.
• Investigation ( Data gathering of Quality issue). 
• Identifying and Implementing  Corrective/Preventive Actions.
• Lead complaint activities with the Operating Units members.

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?