Senior Product Quality Assurance Engineer (I&G)
ResMed · San Diego, CA
QualityFull-time$122k–$184kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Design Quality Engineer ensuring digital health products meet quality, safety, and regulatory standards. Role involves overseeing design controls, verification and validation activities, and guiding product development teams from concept through commercial launch in alignment with FDA and international regulations.
What they're looking for
- Bachelor's in engineering with 5+ years experience or Master's in engineering with 3+ years experience
- Advanced FDA design controls knowledge with product development lifecycle experience
- Advanced IEC 62304 software standard knowledge
- Proficiency with AI tools including VS Code, GitHub Copilot, and ChatGPT
- Experience leading or supporting CAPAs, NCRs, and impact assessments
- Advanced risk management expertise applied during design phase
- Internal and external audit experience in scribe, reviewer, or subject matter expert roles
What you'll be doing
- Develop QA plans for new I&G digital health products ensuring regulatory compliance
- Review and guide product development deliverables from engineering and product teams
- Collaborate with QA, Regulatory, and I&G teams to provide training and quality guidance
- Manage digital health projects and communicate status through executive summaries
- Participate in internal and external audits to verify regulatory compliance
Privacy & handoff
This role links to ResMed's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.