Quality Engineer
. Process Validation, IQ/OQ/PQ. Design Control. Risk Analysis. FMEA. Sustaining engineering....
. Process Validation, IQ/OQ/PQ. Design Control. Risk Analysis. FMEA. Sustaining engineering....
on validation strategies (IQ/OQ/PQ alignment with design intent). Support internal and external audits (FDA, Notified Body, MDSAP...
development. Additionally, it involves funds approval, detailed design, development and fabrication, IQ/OQ/PQ (installation...
activities. Lead supplier-related projects such as process transfers, IQ/OQ/PQ validations, and capacity expansions. Support...
, including authoring or executing validation deliverables (URS, IQ/OQ/PQ, test scripts, traceability matrices) for Salesforce...
), and Performance Qualification (PQ), particularly in regulated or medical device environments. Assist with Factory Acceptance Testing... in customer-facing and field service environments. Experience supporting validation activities such as IQ, OQ, and PQ...
, and continuous improvement methodologies. Experience with equipment validation, IQ/OQ/PQ protocols, and process qualification...
customer validation activities, including IQ/OQ/PQ, and collaborate with Quality and Validation teams in GxP-regulated... 21 CFR Part 11, EU GMP Annex 11, and IQ/OQ/PQ validation processes. Knowledge of low-voltage analog signal wiring...
equipment validation lifecycle, including in-house Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and IQ/OQ/PQ..., and commissioning activities Define and drive full validation lifecycle (IQ/OQ/PQ) including protocol development and execution...
Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Validation Summary Reports Traceability...