QA Inspector 3 Back End Nights
Core
Perform in-process and final product inspection, testing, and documentation review for continuous glucose monitoring (CGM) devices in a cleanroom environment to ensure compliance with regulatory and quality standards before commercial release.
Role type
Senior IC Quality Assurance Inspector (Medical Devices)
Builds
Commercial CGM medical devices for patients with diabetes
Domain
Medical device manufacturing / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
In-process product inspection, final product testing, Good Documentation Practices (GDP), Lot Release transactions, equipment monitoring, troubleshooting test methods, NCMR process initiation, GMP compliance
Preferred skills
Statistical analysis (Minitab), Microsoft Office proficiency
Responsibilities
Perform in-process and final product review of documents for accurate format, signatures, and dating; Perform in-process product inspection and testing for commercial products; Perform transactions related to Lot Release in a defined system; Monitor equipment and instrumentation to ensure cleanliness and safety; Assist in setting up the Lot Release Dept. and associated Lab; Assist in carrying out TMVs and troubleshooting test methods; Initiate and assist with the NCMR process during manufacturing.
Seniority
Mid-Senior, hands-on IC