For Quality Engineering services in the Manufacturing areas. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Science or Engineering and three to five (3-5) years of exposure within the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Demonstrates excellent organizational and communication skills and proficiency with MS Word Excel and statistical software.
Certified Quality Engineer preferred Experience in: Risk management documentation and in ISO 14971/EU MDR regulation, preferred. Statistical sampling and analysis, including DOE design. 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) Work with pFMEA and Risk Management documentation to transfer to the latest GSOP-504 templates and ensure the documentation is following ISO 14971.
Work with project teams to calculate p1 values based on technical documentation and include rationale to statistically support results. Review and approve validations and completion reports for existing products, processes, and equipment as a result of EU MDR effort. Support statistical analysis of the data to support the reports, as required. Interact and coordinate activities with other departments, external vendors, and customers, as required. Perform other related QE duties, as required. 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?
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