, OQ, PQ protocols. Perform Test Method Development & Validation (TMV). Conduct risk management/FMECA, including DFMECA...
per PACS-PQ-0029 and must have a minimum of a 20/25 vision (with correction) Required to lift a minimum of 35 pounds. Lifting...
. Responsibilities Lead quality support for new product introductions and commercialization projects Develop and execute IQ, OQ, PQ...
, and technical capabilities. Experience with equipment IQ/OQ/PQ. Experience in Lean Manufacturing, Operational Excellence...
/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated..., IQ, OQ, PQ, FAI) of new supplier manufactured components. Strong communication skills and ability to work well...
, including URS, FAT, IQ, OQ, PQ, and Validation Report Approval. Manage capital projects from business case development...
including IQ/OQ/PQ, test method validations, and process validations. Lead complex investigations involving nonconformances...
, and capacity planning. Write and execute process and equipment validations (IQ, OQ,PQ). Review prints for new and existing...
or Six Sigma certification preferred Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting...
activities (IQ/OQ/PQ) and leverage Design of Experiments (DOE) to optimize performance Establish best practices, author... development, validation (IQ/OQ/PQ), and statistical methods/DOE Proven ability to solve complex problems and make high-level...