Quality Inspector
Core
Performing incoming and final inspection of medical device components and finished products against specifications to ensure compliance with quality standards.
Role type
Quality Inspector (Medical Device Manufacturing)
Builds
FDA 510(k)-cleared EEG headband devices and AI algorithms
Domain
Medical device manufacturing / Neurotechnology
Deliverable
physical/clinical work
Required skills
Inspection against drawings and specifications, Good Documentation Practices (GDP), nonconformance identification and escalation, SOP compliance, equipment calibration flagging, 21 CFR 820 knowledge, ISO 13485 familiarity
Preferred skills
Associate's degree in technical/scientific field, experience in regulated manufacturing environments
Technologies
None explicitly stated
Responsibilities
Perform incoming and final inspection of components, subassemblies, and finished devices; Record inspection results and maintain Device History Records; Identify nonconforming material and escalate findings; Perform monthly quality inspections of manufacturing areas; Support Quality Engineering with document control, audits, and complaint investigations; Assist with equipment upkeep and calibration flagging
Seniority
Entry-level to Junior (1-2 years experience required)