• Perform thorough inspections of products using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify conformance to specifications.
• Utilize advanced quality management tools like Calypso and coordinate measuring machines (CMM) to gather accurate data during inspections.
• Conduct quality audits in accordance with ISO 13485, ISO 9001, and FDA regulations to ensure compliance with industry standards and regulatory requirements.
• Document inspection results meticulously, including data collection and analysis, to support quality assurance initiatives.
• Identify non-conformances and collaborate with manufacturing teams to implement corrective actions aligned with CGMP (Current Good Manufacturing Practice) and HACCP protocols.
• Participate in root cause analysis and problem-solving activities to improve product quality and process efficiency.
• Support internal and external quality audits by providing detailed reports and maintaining comprehensive records of inspection activities.