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Quality Engineer

3 months ago

Irvine, United States TalentBurst Full time

Short-term (3 months only with no possibility of extension/conversion) contract jobs.

Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1

Location: Irvine, CA (100% onsite)

Duration: 3 Months Contract

Job Description:

This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require a presence on campus.

This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client’s systems/procedures for device investigation and risk assessments of reported complaints from the field.

Education and Experience:

  • Bachelors degree in engineering, 0 - 2 years of experience related work experience required
  • Proficient with the Microsoft Office suite
  • Experience with medical device complaint investigations (CAPAs, NCRs, 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).