Quality Engineer

Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months Contract

Job Description

Education and Experience:Bachelor's degree in engineering, 0 - 4 years of experience related work experience requiredProficient with the Microsoft Office suiteExperience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)Functional, physical, and visual testing of medical device equipment in a laboratory settingExperience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.

Roles and Responsibilities:Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).