Senior Quality Assurance

Job description

Overview: Responsibilities include supporting the development, implementation and maintenance of the company’s Quality Management System and regulatory requirements and supporting product development and supply chain activities, in accordance with company policies and defined quality regulations and standards (e.g. ISO 13485, FDA 21CFR820, GMP, GDP for Medical Devices and cGMP for Drug/Medicinal or Biological Products in EU and USA). This includes, but is not limited to: writing and approving quality procedures and related documentation, performing internal and external quality audits, handling deviations, document control and archiving, training and batch record reviews and participation in product development teams. This will be a full-time, on-site position out of our Sandy Springs office with a move to Alpharetta in July 2026. Qualifications: Education - QA responsibilities - Write quality procedures and related documentation. - Review and approve quality procedures and related documentation, including production-related documentation and verification of study data. - Support maintenance of a document control system, as required, to ensure revision control, release, distributio...