Quality Assurance Auditor

Role The Quality Assurance Auditor supports supplier qualification, approval, and ongoing oversight for manufacturing facilities, ensuring compliance with industry regulations and McKesson quality standards. Responsibilities Conducts on-site audits of domestic and international suppliers to evaluate quality systems, manufacturing controls, and regulatory compliance (FDA, cGMP, ISO). Prepares detailed audit reports, identifies risks, and collaborates with stakeholders to monitor corrective actions. Supports supplier qualification programs and maintains knowledge of applicable regulations. Builds professional relationships with suppliers and partners through extensive travel. Qualifications & Skills Requires 4+ years of experience in quality audits within regulated environments, a bachelor's degree in Science or related field, and strong knowledge of FDA regulations, cGMP, and ISO standards. ISO 13485 Lead Auditor certification is preferred. Demonstrates excellent communication, project management, and organizational skills, with the ability to travel extensively. Additional certifications like ASQ CQA or bilingual skills are advantageous. Key Focus Ensuring product safety, regulatory compliance, continuous quality improvement, and fostering supplier relationships in a highly regulated environment. #J-18808-Ljbffr