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Company: Katalyst Healthcares & Life Sciences
Location: Irvine
Posted on: September 18, 2023

Job Description:

Job Description

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 equipments to determine root cause.
  • ssess 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 determination by 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). Requirements :
    • Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years' experience related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required.
    • Experience in medical device (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.

Keywords: Katalyst Healthcares & Life Sciences, Irvine , Engineer, Engineering , Irvine, California

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