Senior Quality Engineer
, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports...
, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports...
in regulated environments (e.g., CSV, IQ/OQ/PQ). Experience with Agile or hybrid Agile/Waterfall delivery models. Knowledge...
protocols (IQ, OQ, PQ) and summary reports, including data analysis Retrieve and compile data from electronic sources/databases...
and teammates in and efficient, timely and professional manners via the phone, email, bank CRM systems, Loans PQ, DNA..., and procedures and policies in a timely manner. Supports as a back up to the consumer finance system analyst for LOS update (Loans PQ...
), and Performance Qualification (PQ). Support regulatory inspection readiness activities, including documentation reviews, audit... documentation, including Validation Plans, IQ, OQ, and PQ. Understanding of regulatory inspection processes and audit support...
, including molding, assembly, inspection, and packaging. Oversight process validations (IQ, OQ, PQ) and maintain validation...
, specifications, and results in line with quality management systems. Perform Gauge R & R and IQ/OQ/PQ for custom test fixtures...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Maintain and manage Master... Master Validation Plans, IQ/OQ/PQ protocols, and reports. Familiarity with Kneat software is a plus. Ability to work...
(Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs) Ensure compliance with GxP, FDA regulations, and risk-based...
, FAT/SAT, and full lifecycle validation (IQ/OQ/PQ). Act as technical authority for automation systems, providing advanced...