Quality Operations Technician (Weeknight Shift - Onsite)
Core
Perform inspections of raw materials, in-process products, and finished medical devices to ensure compliance with GMP and FDA regulations.
Role type
Quality Operations Technician (IC)
Builds
Medical device products (insulin delivery systems)
Domain
Medical device manufacturing
Required skills
Inspection of raw materials and finished devices, Data entry into electronic systems (SAP, Oracle), Equipment calibration verification, Use of measurement instrumentation (micrometers, calipers, tensile testers), Stereoscope and microscope operation, cGMP compliance enforcement, Discrepancy reporting
Preferred skills
Lab setting experience, Mathematics skills
Technologies
SAP, Oracle Agile, Electronic DHR systems, Word, Excel
Responsibilities
Inspect incoming raw materials, in-process items, and lot qualifications; Assess and complete inspection reports; Generate and maintain quality records; Ensure equipment calibration status; Assist in regulatory audits; Follow standard operating procedures and GMPs; Maintain clean work environment; Use measurement instrumentation; Notify leadership of discrepancies
Seniority
Entry-level, hands-on IC