Product Quality Engineer

VC Backed Startup developing life saving products / Top Compensation

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A bit about us:

Based out of the American Tobacco Campus in Durham, NC our client is focused on groundbreaking technology that resuscitates critically ill patients suffering from shock and sepsis. Our clients flagship products have already been cleared by the FDA and are using commercially across the United states.

This Product Quality Engineer will support multiple products across various stages of lifecycle development. Responsibilities include implementation of design and manufacturing changes, authoring design control documents, developing risk management file documentation, executing verification and validation testing, ensuring product meets quality requirements, and managing quality system requirements.

Why join us?

  • Competitive Base Salary
  • 100% company paid health plan for employees
  • Equity in high-growth start-up (not in lieu of a salary)
  • Flexible Hours
  • Very generous PTO
  • Dental and Vision, FSA, HSA
  • Small team, autonomy
  • Many more great perks!

Job Details

  • BS or MS in Engineering and 3-10 years of work experience
  • Experience with ISO 14971 risk management processes, including authoring risk management file documentation
  • Experience in product lifecycle management and quality for medical products regulated by the FDA
  • Experience with Design Controls including design inputs, design changes, design verification and validation, and design transfer
  • Experience with change management and implementation
  • Ability to work with multiple outside vendors for quality, design, and manufacturing support
  • IEC 60601-1 medical electrical equipment, IEC 62304 medical device software
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Greensboro, NC
Durham, NC
Raleigh, NC
Job Type
$100,000 - $130,000