Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements
Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications
Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards
Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks
Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction
Perform line clearance and verification of inspection
Perform verification of manufacturing documents with component and device drawings
Support the training of other inspectors through work demonstration and feedback
May ensure smooth shift transitions by providing status de-brief of shift activities
Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
Other incidental duties: General work area housekeeping
Qualifications
2 years years experience of previous related experience, including GMP and GDP Required
