Company: Katalyst Healthcares & Life Sciences
Posted on: September 18, 2023
- Investigate complex manufacturing product quality and
compliance issues reported from the field, analyze results,
determine root cause/probable cause, and initiate and review
- 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
- Experience in medical device (cardiovascular, endovascular, or
other critical care/surgical products), healthcare, or a related
- 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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