for AI systems in regulated industries-including IQ/OQ/PQ, computer system validation, and production monitoring for clinical...
validations (IQ/OQ/PQ). Perform First Article Inspections (FAI) and reporting. Develop PFMEA, Control Plans, risk assessments...'s in Engineering (Quality/Mechanical/Biomedical/Industrial). Top Skills (Must Have): Process Validation (IQ, OQ, PQ). Validation...
department to plan and execute part validations using IQ, OQ, PQ methods. Work closely with CPC Product Management and Design...
-based systems Strong understanding of CSV lifecycle concepts including IQ/OQ/PQ or equivalent lifecycle validation models...
(IQ/OQ/PQ) for a medical device production facility. The role involves ensuring that manufacturing systems, equipment... (PQ) activities for manufacturing equipment and processes Develop, review, and execute validation protocols and reports...
, utility systems and facilities, including IQ, OQ, and PQ is preferred. Ability to perform field work Willingness to travel...
regulated field. Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance...
, and structured problem-solving methodologies Lead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs...
and corrective actions Support new and transferred projects using APQP, PPAP and IQ/OQ/PQ methodologies Lead, develop and mentor..., PFMEA and qualification processes (IQ/OQ/PQ) Familiarity with Lean Manufacturing and supplier quality improvement...
and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust...