Senior Product Quality Assurance Engineer (hybrid)

IR Jobs

San Diego, CA, United States
Base: $122,000 - $184,000; bonus/equity: not speci...
Fda design controls
Digital health software applications
Iec62304 and iec82304
The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products

Job Summary

  • The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products.
  • Responsibilities include contributing to and managing digital health projects, providing advice/direction in quality related topics, and leveraging professional expertise to contribute to strategy and drive business results.
  • Employees scheduled to work 30 or more hours per week are eligible for benefits including comprehensive medical, vision, dental, and life insurance, as well as 401(k) and tuition assistance.

Matching Summary

The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products.

Salary

Base: $122,000 - $184,000; Bonus/Equity: Not specified; Benefits: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance

Skills & Requirements

Must-have

  • FDA design controls
  • digital health software applications
  • IEC62304 and IEC82304
  • internal and external audits
  • leading CAPAs, NCRs
  • risk management within design phase

Nice-to-have

  • strong emotional intelligence
  • expert negotiation skills
  • building AI agents
  • statistical analysis for sample sizes

Key Requirements

  • Bachelor's degree in engineering with minimum 5 years experience OR Master's degree with minimum 3 years experience
  • Basic to intermediate understanding of AI tools
  • Prior experience as a key backroom audit member

Work Rights

Not specified

Tailored Resume

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