, specifications, and results in line with quality management systems. Perform Gauge R & R and IQ/OQ/PQ for custom test fixtures...
, Design of Experiments (DoE), and process validations (IQ, OQ, PQ) Manufacturing Process Development & Realization for new...
, including molding, assembly, inspection, and packaging. Oversight process validations (IQ, OQ, PQ) and maintain validation...
, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports...
. Ensure suppliers meet quality and regulatory standards for implantable components. Support process validation (IQ/OQ/PQ...
in regulated environments (e.g., CSV, IQ/OQ/PQ). Experience with Agile or hybrid Agile/Waterfall delivery models. Knowledge...
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...
), 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...
(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...