MDR - Sr Quality Engineer - Exempt
and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed). IQ, OQ and PQ performance...
and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed). IQ, OQ and PQ performance...
, Word, and Project. Process Validation (IQ/OQ/PQ) and Test Method Validation experience. About Us Together, we can...
lead on equipment project management from the URS issue to PQ by applying current project managements practices including...
), and Performance Qualification (PQ) in accordance with industry standards and regulatory requirements. Quality Assurance Process... methodologies, including IQ/OQ/PQ, and risk management tools. Proficient in designing and analyzing quality systems, statistical...
in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability.... Author and maintain IQ/OQ/PQ protocols & reports +validation documentation. Support Master Validation Plans, FMEA/risk...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...
-on experience in Process validation (IQ, OQ & PQ) activities. Lead or support complaint investigations and resolution related... & PQ) activities...
. Expertise in process validation and cleaning validation protocols – IQ/OQ/PQ. Working knowledge of GMP’s, SOP’s, CAPA, auditing...
: Commission and qualify manufacturing work cells through Installation, Operation, and Process (IQ, OQ, PQ) processes. Support...
, PQ) using statistical tools (e.g., Minitab) for data analysis and decision-making. Oversee product testing and analysis...