Quality Assurance Technician performing inspections and testing at Dura - Line. Collaborating with production to uphold safety and quality standards.
About the role
- Senior Product Quality Assurance Engineer at ResMed ensuring compliance of digital health products. Leading project quality strategies and mentoring junior staff while driving process improvements.
Responsibilities
- Contributing to and managing digital health projects with the ability to provide clear/concise executive summaries on overall health of projects.
- Providing advice/direction in quality related topics as it relates to design and development of digital health products.
- Networking and building strong relationships with contacts outside own area of expertise.
- Ability to work independently, with guidance in only the most complex situations.
- Frequently leads sub-functional teams or projects and train and mentor junior team members.
- Serves as a best practice resource within own area of work.
Requirements
- Bachelor’s degree in engineering with minimum of 5 years of experience OR a Master's degree in engineering with minimum of 3 years of experience.
- Advanced knowledge of FDA design controls for new product development with sound knowledge on phase gate design approach.
- Experience with digital health software applications required with working knowledge of IEC62304 and IEC82304.
- Basic to intermediate understanding of Artificial Intelligence tools such as VS Code, GitHub Copilot and ChatGPT required.
- Experience with conducting internal and external audits required.
- Prior experience as a key backroom audit member required (i.e. scribe, document reviewer).
- Experience leading/supporting CAPAs, NCRs and Issue Impact Assessments.
- Experience with risk management tools with clear demonstration of using risk management within the design phase lifecycle.
- Preferred: Advanced knowledge of AI Tools with prior working knowledge of building AI agents.
- Previous experience creating dashboards using JIRA and Confluence.
- Knowledge of statistical analysis with relation to sample sizes.
Benefits
- comprehensive medical
- vision
- dental
- life
- AD&D
- 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 Paid Time Off (PTO)
- 11 paid holidays plus 3 floating days
- 14 weeks of primary caregiver or two weeks of secondary caregiver leave
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