Senior Product Quality Assurance Engineer – I&G

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that both new and existing digital health products from the Incubation & Growth sectors meet quality, safety, regulatory standards, and user needs.

• Supervise design controls as well as verification and validation activities in accordance with quality systems and external regulations.

• Assist in shaping product strategy from the initial concept to commercial launch.

• Conduct specialized quality assurance tasks related to digital health applications and I&G.

• Create project QA plans for new product implementations or modifications to released products.

• Maintain compliance with ResMed’s Quality System, regulatory standards, risk controls, and project timelines.

• Review and provide guidance to Product Development, Engineering, and I&G teams regarding product development deliverables.

• Collaborate with QA, Post Market Quality, QA Production, Regulatory, and I&G team members.

• Deliver project updates, training, and QA guidance.

• Manage and contribute to digital health and I&G initiatives.

• Provide concise executive summaries on project status.

• Offer counsel on quality issues related to digital health product design and development.

• Influence strategic direction and drive business results.

• Foster relationships beyond one's immediate area of expertise.

• Operate independently on daily projects and tasks.

• Serve as a best-practice resource.

• Participate in both internal and external audits to ensure compliance with regulatory standards.

⛳️ Requirements

• Bachelor’s degree in engineering with a minimum of 5 years of experience, or a Master’s degree in Engineering with at least 3 years of experience.

• In-depth knowledge of FDA design controls.

• Practical experience in taking a product from concept to production utilizing a phase gate approach.

• Ideally, experience in an MDR/ISO 13485 environment.

• Advanced understanding of IEC 62304.

• Proficiency with AI tools such as VS Code, GitHub Copilot, and ChatGPT.

• Familiarity with leading or supporting CAPAs, NCRs, and Issue Impact Assessments.

• Advanced skills with risk management tools and proven application during the design phase lifecycle.

• Experience in conducting internal and external audits, including roles such as scribe, lead backroom document reviewer, or front room SME.

• Efficient, self-sufficient, and adaptable.

• Strong written and verbal communication skills, with the ability to negotiate and influence.

• Experience with digital health SaMD applications and IEC 82304.

• Understanding of how to create and deploy custom AI agents.

• Previous experience using JIRA and Confluence in a software product application environment.

• Knowledge of statistical analysis related to sample sizes for testing digital health software applications.

🏝️ Benefits

• Comprehensive medical, vision, dental, and life insurance.

• AD&D insurance.

• 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).

• Tuition assistance.

• Fifteen days of Paid Time Off (PTO) in the first year.

• 11 paid holidays plus 3 floating days.

• 14 weeks of primary caregiver leave or two weeks of secondary caregiver leave.

• Flexible work arrangements.

• Opportunities for personal and professional growth.

• A diverse and inclusive workplace culture.