Quality Engineer
. Support Process/Product Monitoring and Validation, including IQ/OQ/PQ protocols, statistical process control (SPC), process...
. Support Process/Product Monitoring and Validation, including IQ/OQ/PQ protocols, statistical process control (SPC), process...
Qualification (PQ) protocols for new and existing equipment. Ensure equipment meets regulatory standards (e.g., FDA, ISO, GMP... qualification or a related role. Knowledge of equipment qualification protocols (IQ, OQ, PQ). Familiarity with regulatory...
elements (PPAP/FAI, capability studies, MSA/Gage R&R, process validation IQ/OQ/PQ where applicable). Collaborate with Design...
Understanding validation documents, URS, IQ, OQ, PQ Verifying system drawings including ability to review and as-built P&IDs...
Assessment IQ/OQ/PQ Protocols, test scripts and Reports Validation Summary Report Review existing validation documentation...
and systems IQ, OQ, and PQ of fixtures, tooling, and equipment Identify, investigate and resolve manufacturing difficulties...
or assist with qualification activities—including IQ/OQ/PQ—for new equipment, processes, or systems. Documentation & Training...
technical adequacy, statistical validity, and regulatory compliance. Review IQ, OQ, and PQ protocols for completeness...
to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...
, plating, casting, and thermal forming. Experience with APQP (IQ, OQ, PQ) preferred. Experience in technical writing...