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Sr. Quality Control Technician

Company: Stellartech Research Corporation
Location: Milpitas
Posted on: June 24, 2022

Job Description:

Job Description - ESSENTIAL FUNCTION:
1. Review Device History Records.
2. Maintain Device History Record files
3. -Lead and manage the Material Review Board to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions and trending are initiated while meeting all regulatory requirements.
4. Assist in management of calibration program to include maintenance of calibration certificates, log and records, sending out for calibration and follow up on equipment out for calibration.
5. Assist in management of test fixture maintenance program including maintenance of test fixture log, maintenance of test fixture records, and verifying that test fixtures are maintained on schedule.
6. Assist and support in identifying priorities to support operations, delegate responsibilities to the team as needed.
7. Assist environmental monitoring of controlled environment area, including air particle counts, air and surface microbial counts, product bioburden, and monitoring of pressure differential gages.
8. Perform final quality post tests of electrical medical devices prior to release.
9. Perform customer device release records including certificates of conformance records.
10. Perform monthly electrostatic discharge control tests and maintain electrostatic discharge control log.
11. -Aid in processing of customer service requests and complaints.
12. -Other duties as assigned.

EDUCATION AND EXPERIENCE:
Minimum AA's degree preferably in Electronics or related field.
2+ years experience in an FDA-regulated environment.
Working Knowledge of 21CFR820 and ISO 13485.
An organized, analytical thinker with exceptional attention to detail.
A excellent communicator, both oral and written.
Working knowledge of Microsoft Office.

Keywords: Stellartech Research Corporation, Milpitas , Sr. Quality Control Technician, Professions , Milpitas, California

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