Level Agreement. Review and schedule preventive maintenance and other scheduled compliance activities (OQ, PQ...
and other scheduled compliance activities (OQ, PQ and validation) and dispatch, accordingly, coordinating scheduling meeting customer site...
of experience in medical device manufacturing. Proficiency in process validation and documentation (IQ/OQ/PQ). Equipment/tooling...
Qualification (IQ), Process Characterization (DOE), Operational Qualification (OQ), and Performance Qualification (PQ), Process FMEA... qualification and validation of manufacturing process (IQ, DOE, OQ, PQ, Process FMEA). o Founded knowledge and practical experience...
improvements. Support Manufacturing Engineering with process validation (IQ, OQ, PQ) execution for new and updated production...
. Performing validation (IQ/OQ/PQ) protocols, test method validations, test protocols, and associated activities for new...
) and internal SOP's Support onboarding of new instrumentation including performing/reviewing IQ/OQ/PQ data or qualifications...
all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS...
with suppliers. Supports IQ/OQ/PQ validation efforts within Edwards and at suppliers. Ensure proper documentation is completed...
requirements on equipment when needed (IQ, OQ, IOQ, PQ). Be able to comprehend electrical wiring diagrams, pneumatic drawings...