Senior Quality Engineer at Entegee

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)