Director, R&D Quality Engineering
, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP. Able to recognize non-conformances from accepted and documented practices...
, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP. Able to recognize non-conformances from accepted and documented practices...
) protocols and participating in FAT/SAT execution, review of installation, operational, and performance qualification (IQ/OQ/PQ..., operational and performance qualification (IQ/OQ/PQ) protocols Ability to use AutoCAD, Revit, Visio Engineering, communication...
, Operational Qualification (IQOQ), and Performance Qualification (PQ). Support continuous improvement initiatives by exploring...
equipment and processes. You will review and approve equipment acceptance testing (FAT/SAT) and validation protocols (IQ/OQ/PQ...
all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS...
, protocols, risk assessments, engineering studies for facilities equipment, instruments and utilities. Generate needed IQOQ/PQ... documentation for facilities equipment, utilities and tooling (new and old). Execute needed IQOQ/PQ protocols for facilities...
, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work with suppliers to execute...
validations and qualifications including FAT, SAT, IQ/OQ/PQ, and MSA studies. Troubleshoot and develop solutions to address... technologies, including validation protocols (IQ / CQ / OQ / PQ / MSA). Experience and knowledge of vision systems controls...
for automation equipment. Create protocol documentation for equipment DQ, IQ, OQ, PQ Validation as needed. Additional responsibility... execution and support of DQ/IQ/OQ/PQ protocols. Hands on manufacturing line support when needed, including the debug, repair...
relevant experience Nice to Have Design Validation Experience Process Validation Experience including: DOE, TMV, OQ/PQ...