Summary from listing
The Quality Engineer supports Comecer Project Managers with quality management of orders across radiopharma, pharmaceutical, and cell and gene therapy projects in North America. Responsibilities include design reviews, FAT, SAT, IQ, OQ, VPHP cycle development, PQ activities, validation documentation, process controls, regulatory approvals, inspection methods, and corrective actions. The role requires a bachelor’s degree in a technical field or equivalent experience, quality engineering experience in a manufacturing environment, ISO 9001 familiarity, strong communication and problem-solving skills, Microsoft Office proficiency, and the ability to work in an office environment with occasional manufacturing-floor exposure.
