Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic...
of these methods. Support test equipment development and IQ/OQ/PQ validation where applicable. Cross-Functional Leadership...
IQ, OQ, PQ protocol development, execution, and reporting. Partner with tooling, equipment, and material vendors... optimization. Working knowledge of IQ/OQ/PQ and GMP/ISO/cleanroom expectations. Ability to interpret part prints, mold designs...
, and PQ for equipment, tooling, and processes. Develop/improve processes and sampling activities, as well as tooling... IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820. Practical experience using DOE, SPC, and Gage R&R;familiarity...
(OQ), performance qualifications (PQ), and process performance qualifications (PPQ). Maintain communications...
validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR Part 11. Manage calibration programs...
molds using SIM. Perfrom IQ's, OQ' and PQ's. Take part in deveploing PFMEA's and quality documents. Manage technical...
to resolve chronic equipment issues Support development and execution of FAT/SAT, IQ/OQ/PQ, and line acceptance criteria New...
) and Performance Qualification (PQ), test method validation protocols (TMV) and analytical test methods. Provide guidance/direction...
with process, controls, maintenance, and quality teams to resolve chronic equipment challenges. Support FAT/SAT, IQ/OQ/PQ...