Quality Engineer

4 weeks ago


Irvine, United States TalentBurst, an Inc 5000 company Full time

Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1

Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1

Location: 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 required
  • Proficient with the Microsoft Office suite
  • Experience 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 setting
  • Experience 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).

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