**Job Title: Quality Operations Specialist**
The Quality Operations Specialist is tasked with overseeing the shift from product development to commercial manufacturing by ensuring adherence to design transfer protocols and executing quality inspections. This role includes responsibilities for upholding quality system documentation, carrying out environmental monitoring, and examining nonconformities to facilitate continuous improvement. Ideal candidates will possess a bachelor’s degree or equivalent experience, along with 0-5 years in a regulated manufacturing setting. A solid understanding of FDA 820 CFR, ISO 13485, and cGMP quality management systems is essential.
