the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ...
and production readiness, including mold trials, parameter development, and IQ/OQ/PQ execution, ensuring quality, compliance...
and qualification of manufacturing equipment and processes leveraging standard qualification approaches (DQ/IQ/OQ//PQ). Provide...
the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and 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...
/PQ) for new or modified equipment. Conduct root cause analysis and implement corrective/preventive actions to resolve...
/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...
of experience in IQ, OQ & PQ validations. 5+ years of medical device experience Preferred Qualifications: Master’s Degree...
(OQ), and Performance Qualification (PQ) processes. Ensure sterilization and packaging meet regulatory standards... with IQ, OQ, and PQ validation processes. 3-5 years of experience in the medical device industry, preferred. Additional...