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 IndustryBilingual: Spanish and EnglishSoft Skills: Good problem-solving skillsCertifications: Lean Six Sigma Green Belt Shift: 1st and according to business needs. Experience in: Non-Conformance CAPA and Investigations. Identifying and Implementing Corrective/Preventive ActionsGMP regulations. Microsoft Office (Excel, Word, Outlook, PowerPoint, Project), Agile, Maximo, MRO Program, SAP, Agile, and Compliance WireThe 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, globalIdentifies 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 requirementsPerforms system administration and configuration of quality information technology systemsPerforms investigation of non-conformance events. Initiates, recommends, and provides solutions to the Non-Conforming Product as per proceduresVerifies the implementation and effectiveness of non-conforming CAPAExecutes job responsibilities as established in the proceduresEvaluating, Investigating & Completion of Non-ConformanceInvestigation ( Data gathering of Quality issue). Identifying and Implementing Corrective/Preventive ActionsLead complaint activities with the Operating Units membersWHO 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?Powered by JazzHROGu9rO4Sl6
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