Description

 The Quality Engineering Technician is responsible for supporting complaint analysis, root cause

investigations, device testing, product return administration, and process validations as directed by the

Complaint Lead

Job Responsibilities:

 Cleaning and disinfection of lab spaces.

 Decontamination and documentation of complaint samples received in the lab for evaluation purposes.

 Conduct complaint investigations as defined per standard work instructions.

 Collect, record, and analyze sample analysis data accurately.

 Maintain good documentation practices when recording all data.

 Maintain good laboratory practices consistent with biosafety laboratory practices.

 Maintains a clean and organized safe lab work environment.

 Storage and disposal of complaint samples in accordance with applicable procedures.

 Use calibrated laboratory equipment and tools.

 Assist in the development and implementation of Gage R&R and capability studies

 Execute testing defined per IQ, OQ, and PQ protocols.

 Assist in the investigation, root cause analysis, and corrective action activities to

 support NCR’s, CAPA system, customer complaints, and product returns.

 Execute testing required to validate new test methods to support design verification, design validation, or

process validation.

 Identify and escalate all unexpected analysis results to Quality Engineering

Qualification Requirements

 Education: High School Diploma or Associate degree in technical studies

 Minimum 3 years of relevant medical device industry experience.

 Experience using a variety of test equipment, inspection tools, biosafety, and good laboratory practices.

Job Type: Full-time

Salary: $23.51 - $24.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Irvine, CA: Relocate before starting work (Required)

Work Location: In person