Quality Assurance Auditor
Listed on 2026-08-03
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Quality Engineering
Role
The Quality Assurance Auditor supports supplier qualification, approval, and ongoing oversight for manufacturing facilities, ensuring compliance with industry regulations and McKesson quality standards.
ResponsibilitiesConducts 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 & SkillsRequires 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 FocusEnsuring product safety, regulatory compliance, continuous quality improvement, and fostering supplier relationships in a highly regulated environment.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).