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Job Description
The Quality Inspector I is responsible for performing inspections and quality assurance activities to ensure that raw materials, in-process components, and finished medical device products meet established specifications and regulatory requirements. This role supports compliance with FDA Quality Management System Regulations (QMSR), 21 CFR Part 820, ISO 13485, and company quality standards by executing inspection protocols, documenting results, and identifying nonconformances.
Perform inspection and testing activities on incoming materials, in-process components, and finished goods in accordance with approved procedures, specifications, and sampling plans.
Conduct visual, dimensional, and functional inspections using calibrated measuring instruments (., calipers, micrometers, gauges) and test equipment.
Review and verify Device History Records (DHRs), batch records, and other quality documentation for completeness, accuracy, and compliance.