The Quality Inspector is accountable for ensuring quality and overseeing manufacturing processes, including generating certificates of compliance, conducting inspections and tests, determining product disposition, performing incoming inspections, and carrying out in-process and final inspections, as well as reviewing Device History Records (DHRs).

Key Responsibilities include the following:

• Adhering to written procedures for testing and accurately documenting all test results.
• Reporting test data findings that fall outside of specified limits.
• Ensuring compliance with relevant US FDA regulations and ISO 13485 Quality Management System standards by following established procedures.
• Submitting and maintaining test result documentation.
• Collaborating directly with manufacturing and engineering teams to test and inspect components and materials.
• Facilitating the smooth movement of products through quality control for final disposition.
• Providing test and inspection support for the development of new processes.
• Reviewing Device History Records (DHR).
• Analyzing all laboratory results and approving product release.
• Working collaboratively within a team environment with all quality control inspection staff.
• Using manual dexterity to measure with tools such as rulers, calipers, micrometers, and other instruments.
• Undertaking special projects as required.