Principal Quality Engineer #JN -032021-61259

Thousand Oaks, California
Industry: QA Testers
Job Number: JN -032021-61259

***Remote until after COVID****

 

Description:

  • Accountable to ensure quality and compliance associated with client software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches

 Responsibilities:

  • Benchmark with industry regarding quality and compliance models for software medical devices and digital health products
  • Accommodate Agile software development methodology
  • Ensure inspection readiness and maintain CE marks for existing software medical devices
  • Train and mentor relevant staff for development and succession planning
  • Maintain and resource program and project quality support portfolio
  • Collaborate with Senior Management, data management and presentation, provide backup support to other Quality focus areas
  • Work in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business
  • Plan and lead all aspects of major change efforts in the digital health space

 Authority:

  • Assure that current regulatory trends are accommodated in the capability
  • Advise software medical device and digital health product teams as Quality representative
  • Review and approve medical device design control and post-commercial documentation (internally and at times, externally)
  • Interface with regulators and Notified Bodies
  • Review and approve procedures and work instructions

 Basic Qualifications:

  • Doctorate degree and 2 of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
  • Master’s degree and 6 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
  • Bachelor’s degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
  • Associate’s degree and 10 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production OR
  • High school diploma / GED and 12 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production

 


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