Associate, Quality Assurance Engineering

Role: Quality Systems Engineer overseeing manufacturing quality operations in a biopharma or medical device setting, ensuring compliance with GxP, ISO, and internal standards throughout the product lifecycle. Responsibilities include supervising quality personnel, monitoring product quality, conducting audits, managing non-conformances, reviewing batch records, and making release decisions. The role involves supporting product transfers, process improvements, validation, CAPAs, and ensuring regulatory adherence. Requirements: Bachelor's degree or equivalent experience (e.g., high school + 8 years or Associate + 4 years), fluency in English, with experience in quality management within regulated manufacturing environments. High-Value: focus on medical devices or biopharma products, quality assurance, GMP/ISO compliance, batch record review, audits, and supplier management. Work setup: onsite at Johns Creek, GA; relocation and sponsorship not available.