Post Market Surveillance Product Quality Engineer

2 weeks ago

Irvine, United States Compunnel Inc. Full time

Job Description:

The Quality Engineer position within THV Quality Engineering, Global Product Surveillance (GPS), is a critical role responsible for leading and performing engineering investigations on globally reported complaints for returned and non-returned devices. The incumbent will apply their knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and companies systems/procedures for device investigation and risk assessments.

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.
  • Perform other incidental duties assigned by Leadership, such as assisting in ad hoc complaint analysis or metric review.

Education and Experience:

  • Bachelor's Degree or equivalent in Engineering or Scientific field, with 2 years of related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, with 1 year of 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 associated risk assessments preferred.

Additional Skills:

  • Strong 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 problem-solving, organizational, analytical, and critical thinking skills.
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
  • 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

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