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Quality Control Engineer

2 months ago

California, United States Compass Consulting Full time

Company Overview:

Compass Consulting is at the forefront of developing and providing a diverse range of innovative medical diagnostic solutions, including products, services, tests, platforms, and technologies.

Position Summary:

  • The role involves assisting in the establishment and execution of a robust Quality Management System (QMS) along with the necessary tools and infrastructure to ensure compliance with FDA Quality System Regulation (QSR) and International Standards Organization (ISO) standards.
  • Experience in managing changes, Corrective and Preventive Actions (CAPA), and handling non-conformance issues is highly valued.
  • Familiarity with supporting project-related documentation and Quality Management System (QMS) documentation through an Electronic Document Management System (EDMS) is advantageous. This includes aiding in the coordination of document and record retention in accordance with corporate standards.

Key Responsibilities:

  • Review and document test scenarios and cases.
  • Conduct and document risk assessments.
  • Track and report on testing progress and outcomes.
  • Evaluate test plans for thoroughness.
  • Establish standards and procedures to assess product quality and readiness for release.
  • Promote innovation and enhance overall testing methodologies.
  • Identify potential user issues and challenges.
  • Investigate and analyze features of the products under evaluation.
  • Explore new tools, technologies, and testing methodologies.
  • Assess user interfaces for consistency and functionality.

Qualifications:

  • 2-4 years of relevant experience in the medical diagnostics or device sector, including 1-2 years in direct quality operations.
  • Experience in quality systems, regulatory compliance, or project management is essential.
  • Knowledge of international ISO standards (13485, 62304, 14971) and regulations related to medical and in-vitro devices.
  • Certifications such as ASQ Certified Quality Engineer (CQE), Auditor (CQA), or Six Sigma Green Belt are advantageous.
  • Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is preferred.

Education:

  • A Bachelor's degree in Biological Sciences, Engineering, or a related field, or an equivalent combination of education and experience.