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.
5. Working knowledge of Microsoft Office.
6. Working knowledge of 21 CFR 820 and ISO 13485.
7. 2-4 years of relevant work experience.
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