Senior Digital Health QA Engineer (I&G)

ResMed Inc; San Diego (CA); Hybrid; USD 122,000 - 184,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work arrangements

PTO & holidays

Career development

Job summary

ResMed Inc in San Diego, CA, seeks a Senior Product Quality Assurance Engineer to drive design controls for digital health products from concept to launch. You will develop QA plans, review development deliverables for regulatory compliance, and collaborate with QA, Regulatory, and I&G teams while leading audits and providing clear status updates on projects.

Requires strong knowledge of ISO 13485, MDR, IEC 62304, and experience with CAPAs, NCRs, risk management, and audits.

Qualifications

• Bachelor’s in engineering with at least 5 years of relevant experience.
• Advanced knowledge of FDA design controls and product lifecycle from concept to production.
• Experience with MDR/ISO 13485 environments and IEC 62304 software standard.
• Experience leading CAPAs, NCRs, and impact assessments.
• Proficiency in risk management and quality system processes.
• Audits experience, as scribe or SME roles.
• Strong communication and collaboration skills.

Responsibilities

• Develop QA plans for new product implementations and changes.
• Review development deliverables to ensure compliance with quality systems.
• Collaborate with QA, Regulatory, and I&G teams to support QA guidance.
• Lead or participate in internal and external audits.
• Provide executive summaries on project status.
• Support strategy from concept to commercial launch.

Skills

FDA design controls

Product quality assurance

CAPAs and NCRs

Risk management

Audits leadership

Regulatory knowledge

Education

Bachelor’s or Master’s in Engineering

Tools

VS Code

GitHub Copilot

ChatGPT

JIRA

Confluence

Job description

ResMed Inc in San Diego, CA, seeks a Senior Product Quality Assurance Engineer to drive design controls for digital health products from concept to launch. You will develop QA plans, review development deliverables for regulatory compliance, and collaborate with QA, Regulatory, and I&G teams while leading audits and providing clear status updates on projects.

Requires strong knowledge of ISO 13485, MDR, IEC 62304, and experience with CAPAs, NCRs, risk management, and audits.