& Qualification Life Cycle Lead IQ/OQ/PQ strategies for equipment, processes, packaging, and software where applicable. Develop...
calibration, monitoring, SPC, standards and other tools and processes. Support new equipment installation (IQ/OQ/PQ...
for AI-driven decision-making systems. Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports...
preventive and unscheduled maintenance activities on their equipment within their assigned work center. Support IQ, OQ, and PQ...
results from 1st article and Process validations (IQ-OQ-PQ) studies during product launch and subsequent changes to tooling... process, such as process improvement, problem-solving, AQL Levels, FMEA, validations (IQ/OQ/PQ), DOE, and metrics. Provide...
with PowerShell scripting for automation and validation tasks. ⦁ Experience in software validation methodologies, including IQ/OQ/PQ...
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...
, and reports. Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ). Use statistical tools such as Minitab...
: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim... (Operational Qualification), and PQ (Performance Qualification) protocols and reports. Proficiency in developing and executing IQ...
qualification (IQ, OQ, PQ). Develop, review, and execute validation protocols and reports in compliance with GMP standards...