Quality Engineer II

• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  
• 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 for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  
• Reports on the status of validation activities to fulfill regulatory requirements.
  
• Performs system administration and configuration of quality information technology systems.
  
• Performs investigation 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
  
• Follows the documentation procedures Non- Conformance Resolution
  
• Evaluating, Investigating & Completion of Non- Conformance
  
• Investigation ( Data gathering of Quality issue)
  
• Identify Corrective/Preventive Actions
  
• Implementing Corrective/Preventive Actions
  
• Lead complaint activities with the Operating Units members
  
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Requirements

• Minimum 2 years of relevant experience in the regulated industry.
  
• Knowledge of Good Manufacturing Practices.
  
• Bilingual.
  
• Lean Six Sigma Green Belt Certification.
  
• Microsoft Office (Excel, Word, Outlook, Power Point, Project), Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool.
  
• Good problem-solving skills
  
• Bachelor degree in Engineering completed.
  
• Availability to work overtime and weekends when necessary.
  
• Willing to work 100% On-site in Villalba.