THV Quality Assurance Specialist

1 month ago


Irvine, California, United States Entegee Full time
Job Overview

We are seeking a highly skilled THV Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and compliance, with experience in medical device testing and investigation.

The successful candidate will be responsible for investigating product quality issues, performing device testing, and managing complaint investigations. They will also be required to analyze results to determine root causes and probable causes, and participate in escalation tasks such as Project Risk Assessments and Corrective/Preventive Actions.

The THV Quality Assurance Specialist will work closely with manufacturing teams to resolve production/device related issues, and will be responsible for reporting key complaint metrics by device category.

The ideal candidate will have a Bachelor's degree in engineering, with 0-2 years of related work experience. They will also have experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis.

Benefits include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan.

Key Responsibilities:

  • Investigate complex product quality and compliance issues from the field
  • Perform hands-on device investigation using various test equipment
  • Assess events against risk documentation for clinical/compliance risks
  • Participate in escalation tasks such as Project Risk Assessments and Corrective/Preventive Actions
  • Report key complaint metrics by device category

Requirements:

  • Bachelor's degree in engineering
  • 0-2 years of related work experience
  • Experience with medical device complaint investigations
  • Proficiency with the Microsoft Office suite


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