: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders...
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...
for AI systems in regulated industries-including IQ/OQ/PQ, computer system validation, and production monitoring for clinical...
, and structured problem-solving methodologies Lead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs...
and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust...
, utility systems and facilities, including IQ, OQ, and PQ is preferred. Ability to perform field work Willingness to travel...
department to plan and execute part validations using IQ, OQ, PQ methods. Work closely with CPC Product Management and Design...
validation (IQ/OQ/PQ), and full production ramp Define process flow diagrams (PFDs), equipment requirements, controls interfaces... manufacturing processes Familiarity with equipment qualification (IQ/OQ/PQ), control plans, APQP, and ISO 9001 / IATF 16949...
, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans Perform and lead risk assessments, gap... with Computer Systems Validation (CSV), CQV, or automation validation Experience writing and executing IQ/OQ/PQ validation...
Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for manufacturing equipment and processes...