Quality Control Inspector
Core
Performing inspections at various stages of production for spinal and orthopedic implants and instrumentation cases to ensure product and raw material quality meets standards.
Role type
Quality Control Inspector (Medical Devices)
Builds
Spinal and orthopedic implants and instrumentation cases
Domain
Medical device manufacturing (orthopedics/spine)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
inspection of raw materials and subassemblies, handling of fixtures and equipment, maintenance of quality inspection records per GMP, editing and proofreading documentation, archiving of quality records, identification and segregation of nonconforming material, execution and review of Device History Records (DHRs), use of QAD system, reading technical documents (job travelers, plans, sketches), fundamental geometry and measurements, close vision and color vision
Preferred skills
experience in class II or III medical device environment, complaints lab inspection, receiving inspection, inspection of small components using a microscope, knowledge of FDA QSRs and ISO 13485, experience with QAD, IPC-A-610 certification or knowledge of medical device component welding (resistance, spot, laser), handling of electrical components, experience with ESD processes, knowledge of measurement instruments and sample plans
Technologies
QAD, Microsoft Office
Responsibilities
Carry out inspection activities to ensure quality of products and raw materials, ensure consistency and quality of records by editing and proofreading documentation, maintain and archive documents for compliance, schedule periodic document reviews, communicate corrections and improvement opportunities, ensure timely release of subassemblies and assemblies, control nonconforming material, interface with cross-functional teams, label and segregate components, notify departments on material holds, support external audits, adhere to company and industry codes of conduct, complete compliance training
Seniority
Mid-level, hands-on IC