Senior Product Quality Assurance Engineer (I&G)

$122k - $184k

ResMed Inc

ResMed seeks a Senior Design Quality Engineer to ensure digital health products from the Incubation & Growth division meet quality, safety, and regulatory standards. The role involves overseeing design controls, verification and validation activities, and supporting products from concept through commercial launch in compliance with FDA and international regulations.

Responsibilities

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

Requirements

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

Compensation: $122,000 - $184,000 base

Apply

Vacancy posted 26 days ago

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