/OQ/PQ and FAT/SAT (as applicable) aligned with process risk assessments and critical requirements. Manage engineering..., Control Plans, DOE, SPC, MSA (GR&R), and validation (IQ/OQ/PQ). Hands-on experience with automation and controls (vision...
including repairs and pm work § Works with new tool IQ, OQ, PQ process, DOE runs and process studies § Plans, organizes...
capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues...
IQ, OQ, and PQ. Support the development of CQV plans, risk assessments, and traceability matrices. Perform...
knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc. Advanced verbal and written...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work...
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...
implementation/validation (IQ, OQ, PQ) Confer with management, engineering, and other staff regarding manufacturing capabilities...