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Quality Complaints Engineer

Location: Irvine
Posted on: March 15, 2023

Job Description:

Job Description:

Pay Range: $44.70 - $49.70


  • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
  • 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.

      Additional Skills:

      • Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
      • Basic understanding of statistical techniques.
      • Previous experience working with lab/industrial equipment required.
      • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
      • Solid problem-solving, organizational, analytical and critical thinking skills.
      • Solid understanding of processes and equipment used in assigned work.
      • Knowledge of and adherence to Quality systems.
      • Strict attention to detail.
      • Ability to interact professionally with all organizational levels.
      • Ability to manage competing priorities in a fast-paced environment.
      • Must be able to work in a team environment, including the ability to manage project stakeholders.
      • Ability to build productive internal/external working relationships.

Keywords: CYNET SYSTEMS, Irvine , Quality Complaints Engineer, Engineering , Irvine, California

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