the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ...
and qualification of manufacturing equipment and processes leveraging standard qualification approaches (DQ/IQ/OQ//PQ). Provide...
of experience in IQ, OQ & PQ validations. 5+ years of medical device experience Preferred Qualifications: Master’s Degree...
to corroborate equipment design and application to include (but not limited to) commissioning items, FAT, SAT, IQ/OQ/PQ, calibration...
and production readiness, including mold trials, parameter development, and IQ/OQ/PQ execution, ensuring quality, compliance...
the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ...
/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports. Establish and enforce traceability... hands-on IQ/OQ/PQ execution and risk-based validation approaches. Strong working knowledge of GxP regulations, FDA 21 CFR...
and modeling software (e.g., Aspen Plus or SuperPro Designer). Experience with validation protocols, including IQ/OQ/PQ...
and Key Behaviors, we want to hear from you. Responsibilities: Lead qualification and validation activities (IQ, OQ, PQ... documentation: URS, FRS, DS, IQ, OQ, PQ, PV, CSV, MVP, and more. Solid understanding of cGxP principles, ISO 13485, ISO 14971, 21...
. Must meet EEC Educator Professional Development requirements;PQ Registry to reflect all trainings. CPR and 1st Aid...