Our client in Milpitas, CA, a Medical Device Manufacturing company, is looking for a QC Control Technician. This position offers a long-term contract with potential for permanent hire. Interviews will commence after July 8th, though we are currently welcoming applications from interested candidates.
Pay Rate Range $25-29/hr
JOB TITLE: Quality Control Technician II
REPORTS TO: Quality Control Manager
ESSENTIAL FUNCTIONS:
1. Prepare/assemble, review, and approve Device/Lot History Record (DHR/LHR) documentation to effect finished product release, to include Certificate of Conformance (CofC) issuance.
2. Maintain up-to-date DHR/LHR files, including electronic versions.
3. Prepare sterile disposable products for shipment to the sterilizer, including all necessary / ancillary paperwork.
4. Assist in management of the equipment calibration/PM program, to include induction of new equipment into the program, sending equipment out for calibration/PM, proper documentation/stowage of inactivated equipment, and maintenance of records.
5. Assist in management of the Controlled Environmental Area (CEA), including scheduling service and reviewing & reacting to various reports/records -- e.g., environmental monitoring reports, product bioburden reports, cleaning records, and differential pressure monitoring records.
6. Perform final inspections, including Power-On-Self-Testing (POST) and visual inspection of finished medical devices prior to release.
7. Perform monthly electrostatic discharge control (ESD) tests and maintain ESD logs for Mfg, CEA, R&D, IQC, and stockroom.
8. Assist in maintenance & management of various QMS subsystems -- including, but not limited to Environmental Monitoring, Service Record Processing, Non-Conforming Material Handling, Manufacturing Deviation Authorizations, and Rework Orders. 9. Other duties as may be assigned.
EDUCATION AND EXPERIENCE:
1. Minimum high school diploma.
2. An organized, analytical thinker with exceptional attention to detail.
3. An excellent communicator, both oral and written.
4. Capable of interpreting data, identifying root causes.