Medical Device Quality Assurance Specialist

3 weeks ago


Irvine, California, United States Entegee Full time
Job Overview

We are seeking a skilled Medical Device Quality Assurance Specialist to join our team. This role will be responsible for investigating product quality issues, performing device testing, and managing complaint investigations in the medical device industry.

Responsibilities
  • Investigate complex product quality and compliance issues from the field; analyze results to determine root causes/probable causes.
  • Perform hands-on device investigation using various test equipment to determine root cause.
  • Assess events against risk documentation for clinical/compliance risks; escalate as necessary.
  • Participate in escalation tasks such as Project Risk Assessments (PRA) and Corrective/Preventive Actions (CAPAs), SCARs based on investigation findings.
  • Report key complaint metrics by device category; collaborate with manufacturing teams to resolve production/device related issues.
Requirements
  • Bachelor's degree in engineering with 0 - 2 years of related work experience.
  • Experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis.
  • Proficiency with the Microsoft Office suite.
  • Experience performing functional, physical, and visual testing of medical equipment in a laboratory setting.
  • Basic understanding of statistical techniques.
  • Solid knowledge of engineering principles, theories, and concepts.
  • Familiarity with Quality systems and adherence to their regulations.
Preferred Skills
  • Experience in the medical device field (cardiovascular, endovascular or critical care/surgical products).
  • Good documentation skills along with strong communication and interpersonal relationship abilities.
  • Previous experience working with lab/industrial equipment.
Salary Range

$35-$40 per hour

Benefits

Our company offers competitive benefits, including medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. We provide employees with the flexibility to choose the type of coverage that meets their individual needs.



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