For Quality Engineering services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and at least (5+) years of experience performing quality engineering functions within a manufacturing environment . Bilingual: (Spanish and English). Soft Skills: Problem-solving, excellent time management, and good decision-making. Lean Six Sigma certification preferred.
Shift: Administrative and according to business needs. Experience in: Medical device industry Write technical reports and documents Microsoft Excel data migration Developing and reviewing pFMEA documents 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 Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provide guidance and support for Excel data migration from current Process Risk Assessment documents to a new Excel process Failure Mode and Effect Analysis (pFMEA's) format.
Must be able to interpret/ understand process Failure Mode and Effect Analysis (pFMEA's) - Global Work Instruction.
Providing technical expertise and support for process Failure Mode and Effect Analysis (pFMEA's) assessments for Juana Diaz (PRMO/ PRPO) manufacturing site in-line and other support processes.
Must be able to evaluate multiple systems (Incoming, Receiving, Infrastructure, Formulation (Monomer & Solution) Laboratories, Dry & Wet Lens Manufacturing Processes, Sterilization, Packaging, etc.)
to generate and or review pFMEAs and identify existing or potential gaps.
Must be able to Identify and evaluate process Failure Mode and Effect Analysis (pFMEA's) enhancements.
Good understanding of GMP, GDP, and GLP guidelines.
As needed, provides support for ongoing compliance initiatives, assessments, remediation/ corrective actions, and training.
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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