data and establish validated process windows. Prepare and update PODs, FW redlines, and OQ/PQ documentation. Define mold.... Required Skills Mold Qualification | Injection Molding | Mold Validation | RJG Data | Process Windows | OQ/PQ | PODs | Quality...
, service upgrades, disposable kits, and spare parts. Will participate and support the SAT, IQ/OQ and PQ activities for new...
Experience *Equipment & Process Validation Experience ( IQ, OQ, PQ)...
validation activities during DQ, FAT, IQ, OQ, SAT and PQ phases. Establish, manage, and maintain automation project budgets...
engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE... Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new...
), and Performance Qualification (PQ) activities. Ensure calibration readiness, data integrity verification, and compliance with 21 CFR...
of GMP, ISO, FDA requirements, and IQ/OQ/PQ validation is preferred. Strong communication, problem-solving, and vendor...
/PQ for lab equipment or processes Documentation practices aligned with audit-ready and traceable systems Lab... activities (IQ/OQ/PQ) and overall lab operations....
controls, and validation reports. Support and execute IQ/OQ/PQ activities for analytical instruments, computerized systems... with analytical laboratory instrument qualification and GMP equipment qualification. Strong understanding of IQ/OQ/PQ, GxP, cGMP, 21...
Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R) Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab..., and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R...