Senior Product Quality Assurance Engineer (hybrid)

ResMed

Base: $122,000 - $184,000; bonus/equity: not speci...
Hybrid
Bachelor's or master's degree in engineering
5 years experience in engineering
Fda design controls knowledge
ResMed is seeking a Senior Product Quality Assurance Engineer with expertise in digital health products to ensure compliance with quality and safety standards. The ideal candidate will have a strong background in FDA design controls, experience with digital health applications, and the ability to work independently while leading teams

Job Summary

  • The role ensures new and sustaining digital health products meet quality, safety standards, and regulatory requirements.
  • Employees are eligible for comprehensive benefits including medical, vision, dental, life insurance, and a 401(k) plan.
  • The position offers a competitive base salary range of $122,000 to $184,000 with flexible work arrangements.

Matching Summary

Match Score: 85

ResMed is seeking a Senior Product Quality Assurance Engineer with expertise in digital health products to ensure compliance with quality and safety standards. The ideal candidate will have a strong background in FDA design controls, experience with digital health applications, and the ability to work independently while leading teams.

Salary

Base: $122,000 - $184,000; Bonus/Equity: Not specified; Benefits: Comprehensive medical, vision, dental, life, AD&D, disability, HSA, FSA, commuter benefits, 401(k), ESPP, EAP, tuition assistance, 15 days PTO, 11 paid holidays plus 3 floating days, caregiver leave

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in engineering
  • 5 years experience in engineering
  • FDA design controls knowledge
  • IEC62304 and IEC82304 standards
  • Internal and external audit experience
  • CAPA and NCR management
  • Risk management in design lifecycle

Nice-to-have

  • Advanced AI tools proficiency
  • Building AI agents experience
  • JIRA and Confluence dashboard creation
  • Statistical analysis for sample sizes
  • Strong emotional intelligence
  • Expert negotiation skills

Key Requirements

  • Bachelor's degree in engineering with 5+ years experience
  • Master's degree in engineering with 3+ years experience
  • Experience as key backroom audit member
  • Working knowledge of FDA design controls
  • Prior experience leading CAPAs and NCRs

Work Rights

Not specified

Tailored Resume

Cover Letter