Quality Engineer at Philips


Quality Engineer

United States of America – Home Based

Job Description

In this role, you have the opportunity to

Be a trusted advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

The Quality Engineer (QE) provides quality support to processes related to the installation and servicing of medical devices, new service development, and improvement of quality systems and practices. This includes compliance to regulatory requirements and/or procedures, remediation to non-conformances, and the development and improvement of Quality systems.

You are responsible for:

  • Ensure compliance with Quality Management System, in accordance with Philips Policy, applicable worldwide regulations and standards (FDA / ISO / EU-MDR)
  • Ensures that appropriate quality plans are developed and executed that supports Quality and Regulatory compliance through all stages of change management
  • Performs independent technical assessment on service product quality development and performance
  • Assesses Quality and Regulatory compliance through internal audits and assessments
  • Leads quality related problem solving and root cause analysis, gaining commitment of cross functional resources
  • Analyzes quality monitoring data sources and applies statistical techniques to identify existing and potential causes of non-conformances
  • Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Independently produces and completes documents.
  • Working effectively with all levels of management to ensure that quality plans and / or corrective action plans can be supported

To succeed in this role, you should have the following skills and experience:

  • Bachelor’s degree in an engineering or science discipline
  • 5+ years’ experience in Medical Device Manufacturing and/or Servicing
  • Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and problem solving.
  • Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
  • Strong Project Management skills, including ability to project manage all CAPA activities.
  • Ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions
  • Strong attention to detail
  • Needs to be extremely technically savvy – experience with developing user requirements is ideal.

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