Job Description

-Quality Control Technician is responsible for the execution of deliverables and outputs for the Quality Management system.

-Inspect and approve raw materials, components, packaging materials, work-in-progress, labels, and finished devices per standard QC procedures and the Quality Assurance Manual

-Notify appropriate personnel when Quality Control problems arise

-In-process and finished product clean room laboratory testing to ensure product and process meet quality standard of FDA, ISO13485

-Document and route all required GMP forms and documents accurately and in a timely fashion

-Device History records, QC request system and Material Rejection System

-Maintenance of QC laboratory

-Exercise proficient familiarity with Quality Assurance Manual, recommending changes and/or additions through Supervisor.

Qualifications

Education/Training:

-2+ years lab experience

-ISO 13485, Medical Devices training a plus

-Good oral and written communication skills

-Mathematical aptitude