Position Overview
The Manager – Quality Systems supports Resmed’s Global Quality Systems by leading quality system projects, driving Corrective & Preventive (CAPA) & Computer Software Assurance (CSA) excellence. This role manages cross-functional initiatives that strengthen compliance, improve processes, and ensure the effectiveness of the CAPA & CSA System & Process.
Let’s Talk About Responsibilities
Contribute to quality system capability building, through workflow automation, AI integration, digital enablement, and process standardization.
Lead and deliver quality system projects that improve global QMS processes, CAPA performance, documentation practices, and compliance.
Provide CSA guidance and partner with IT and functional teams to embed risk-based, CSA-aligned methodologies.
Facilitate & Monitor timely completion of CAPA’s, ensuring investigations and reports meet ISO 13485, FDA 21 CFR 820, MDR, and other global regulatory expectations.
Partner with IT squads to enhance, and maintain digital Quality platforms using Agile methodologies.
Build productive relationships to support audit readiness and documentation quality.
Serve as a subject matter resource for CAPA methodology, root cause analysis, risk management, and continuous improvement tools.
Let’s Talk About Qualifications & Experience
Required
Bachelor’s degree in Engineering, Science, Quality, or related discipline.
Minimum 5 years’ experience in Quality Systems, CAPA, or QA/RA roles within a regulated industry.
Demonstrated ability to lead cross-functional projects and manage complex quality investigations.
Strong understanding of ISO 13485, FDA QSR, EU MDR, and global regulatory frameworks.
Ability to work independently, exercise sound judgment, and solve complex problems.
Strong stakeholder management, communication, and influence skills.
Preferred
Experience with eQMS platforms and GenAI digital workflow tools.
Experience mentoring junior QA team members or leading sub-functional initiatives.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
