knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc. Advanced verbal and written...
) and equipment qualification (IQ/OQ/PQ). ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions) The work...
Management System. Support execution of process and equipment validations IQ/OQ/PQ/MVP/TMV). Create process documentation...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.) Provide guidance during protocol...
history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes...
are required. Experience using Maximo is required. Technical writing skills preferred. Exposure to IQ/OQ/PQ preferred. Good...
to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...
Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
regulated device manufacturing Experience completing validation activities including IQ/OQ/PQ, process characterizations...