Intellectt Inc

complaint handling / Quality Engineer @Irvine, CA

Intellectt Inc Irvine, CA
Intellectt Inc

complaint handling / Quality Engineer @Irvine, CA

Intellectt Inc Irvine, CA
3 months ago 44 applicants

See who Intellectt Inc has hired for this role

Role: Quality Engr II

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.

  • Seniority level

    Entry level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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