Work from Office
Full Time
ResMed s products and manufacturing operations must comply with regulatory requirements for medical devices in various markets. The QA Department ensures that management systems are in place to support the design, development, and delivery of products that meet customer quality expectations while complying with regulatory standards. Responsibilities and Accountabilities: Develop project QA plans to ensure efficient new product implementation and product changes that meet quality system, regulatory requirements (ISO13485, CFR820, MDSAP), risk, and project timing. Advocate customer expectations for product quality and reliability, providing timely input and identifying, evaluating, and escalating risks that impact product quality/reliability/field performance. Review and evaluate quality risks related to project compliance and escalate when needed. Review Product Development deliverables to ensure timely and accurate completion. Manage or support responses to audit findings and CAPAs in Product Development. Collaborate with other QA, Regulatory, and Development teams to provide updates and support quality guidance to project teams. Identify and drive process improvements in collaboration with development teams and stakeholders. Qualifications and Experience: Degree in Engineering, Computer Science, Science, or other relevant qualifications.
Resmed
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