QC Technician

Quality Control Technician

This position requires at least two years experience in quality control. The technician must have an understanding of digital and analog circuitry as well as experience with electromechanical components. Also, he/she should have a strong background in electronic instruments.

• Interacts with manufacturing personnel to ensure quality product.

• Interacts with Sales department regarding returned products for repair estimate.

• Assist sustaining engineer in quality functions.

Responsibilities:

• Performance of all testing - visual, functional, safety, burn-in using approved standard operating procedures in compliance with Medical Devices Quality Systems, ISO 13485 and other activities as required.

• Maintenance of quality records.

• Maintenance of test fixtures and test instrument. If they are out-of tolerance, report failure to Quality Control Supervisor and/or Quality Assurance/Regulatory Affairs Manager.

• Identify all non-conforming materials, work in-process failure, and non-conforming final product. Complete appropriate non-conforming and work in-process reports, as applicable.

• Ensure that the non-conformance report is clear and concise. Identify root cause, if applicable.

• Identify and record any product quality problem, and identify changes to procedures; which will further ensure quality of the product. Report all findings to Quality Control Supervisor and/or Quality Assurance/Regulatory Affairs Manager.

• Analyze, troubleshoot and test products returned for repair and/or retest.