Manufacturing Engineer
the validation/qualification effort for equipment and processes (IQ, OQ & PQ). Maintain working knowledge of company...
the validation/qualification effort for equipment and processes (IQ, OQ & PQ). Maintain working knowledge of company...
, and Kaizen. Perform equipment qualifications (IQ, OQ, PQ) and process validations to ensure compliance with regulatory...
, thermography, oil analysis). Experience troubleshooting equipment commissioning/qualification (IQ/OQ/PQ) and completing compliant...
/requalification (IQ/OQ/PQ) and maintain environmental monitoring programs (particulates, temperature, humidity, differential pressure... validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, GMP, and internal quality standards. Ensure all processes...
/OQ/PQ). Provide assistance and/or perform inspection, and electrical safety testing. Ability to perform basic statistical...
readiness. Oversee prototype builds, tooling design/build, and validation activities (IQ/OQ/PQ). Align manufacturing readiness...
Validation & Product/Equipment Transfer Lead and execute process and equipment validations (IQ/OQ/PQ) for new, transferred... activities (IQ/OQ/PQ) and establish environmental monitoring programs (particulates, temperature, humidity, differential pressure...
(customer). Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
, and direct-labor manufacturing personnel. Knowledge of DFMEA, PFMEA, Control Plans, IQ/OQ/PQ Ability to define problems...