Quality Engineer

poistion-Quality Engineer

Location:

Irvine, CA - 92614

Duration:

3 Months

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

Key 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 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 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).

Education And Experience

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 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.

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