. Create process flow diagrams, work instructions, PFMEAs, and validation protocols (IQ/OQ/PQ). Collaborate with suppliers...
, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work with suppliers to execute...
and prepare technical reports Perform IQ/OQ/PQ and maintain lab equipment Follow safety procedures and good laboratory practice...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...
and validation – DOE, PCR, TMV, IQ, OQ, PQ) 2. Statistics 3. Strong problem solving skills Education Required: Advanced degree...
/PQ Qualification Protocols/Issues/Reports, Risk assessments (potential to facilitate risk assessments)). Independently...
efficiently through TrackWise for review and approval. Job Duties: Author, execute, and finalize IQ/OQ/PQ protocols for DeltaV... platforms. Proven experience writing and executing CSV/CQV validation protocols (URS/FRS/IQ/OQ/PQ). Ability to interpret...
, and reports. Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ). Use statistical tools such as Minitab...
such as Control Plans, PFMEA, MSA, and FAI. Support PPAP execution and ensure robust qualification using IQ, OQ, and PQ processes...+ years of experience in supplier quality engineering within medical devices. Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA...
Manufacturing and QA with Performance Qualification (PQ) activities if applicable. Related Activities: Participate or lead...