Quality Engineer I

5 days ago

Irvine, California, United States eTeam Full time

Job Title:
Quality Engineer I

Job Location
- Irvine, CA

Duration
- 18 months

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. This role involves collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties

  • Develop and execute plans for quality and control to ensure manufacturing continuity and product conformance.
  • Lead investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
  • Monitor and analyze product performance of medical devices using a statistical and risk-based approach, considering any quality, compliance, customer, and business risks.
  • Perform hands-on troubleshooting of customer returned devices and manufacturing nonconformities and complete associated technical documentation.
  • Develop tools to communicate complex technical problems and solutions to a variety of audiences within the organization.
  • Proficient in project management, data analysis, root cause analysis, communication, and risk determination.
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Minimum Requirements

  • Bachelor's degree in Engineering.
  • 2 years of relevant experience in a regulated industry (FDA environment preferred).
  • Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.

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