Senior Quality Engineer at Entegee

3 weeks ago QA Senior Full-Time
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We are looking for someone to Maintain and resource program and project quality support portfolio


Basic Qualifications:

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


Key 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
  • Maintain and resource program and project quality support portfolio
  • Plan and lead all aspects of major change efforts in the digital health space
  • 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
  • Interface with regulators and Notified Bodies
  • Review and approve procedures and work instructions

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Job Type: Full-time

Pay: $70.00 - $80.00 per hour

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Vision insurance

Application Question(s):

  • On a scale of 1-10, rate your experience with Agile software development methodolgy.

Education:

  • Bachelor's (Preferred)

Experience:

  • Software medical device quality and compliance concepts: 3 years (Preferred)
  • start to finish digital devices, health tech, and products: 3 years (Preferred)

🌍 World Wide agile qa
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