Are you a quality systems leader passionate about driving compliance and innovation in a global medical technology environment? ResMed is seeking a Manager, Quality Systems to strengthen our global quality framework by leading strategic initiatives in Corrective & Preventive Action (CAPA) and Computer Software Assurance (CSA). In this pivotal role, you will manage cross-functional projects that enhance process effectiveness, integrate digital solutions, and ensure readiness for global regulatory standards. You will be a key player in building a more robust, agile, and forward-looking Quality Management System (QMS).
Key Responsibilities
Process Excellence & Digital Enablement
- Drive quality system capability building through workflow automation, AI integration, and digital tool implementation.
- Lead end-to-end quality system projects to improve global QMS processes, CAPA system performance, documentation practices, and compliance posture.
- Partner with IT and functional teams using Agile methodologies to enhance and maintain digital Quality platforms (e.g., eQMS).
CAPA & CSA Leadership
- Serve as the subject matter expert for CAPA methodology, root cause analysis (RCA), risk management, and continuous improvement tools.
- Facilitate and monitor the timely completion of CAPAs, ensuring investigations and reports meet ISO 13485, FDA 21 CFR 820, EU MDR, and other global regulatory requirements.
- Provide CSA (Computer Software Assurance) guidance, partnering with IT to embed risk-based, efficient assurance methodologies across computerized systems.
Compliance & Collaboration
- Build productive cross-functional relationships to support audit readiness and elevate overall documentation quality.
- Act as a key liaison during internal and external audits, representing the CAPA and CSA processes.
Qualifications & Experience
Required
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related technical discipline.
- Minimum of 5 years of experience in Quality Systems, CAPA management, or QA/RA roles within the medical device, pharmaceutical, or another heavily regulated industry.
- Proven track record of leading cross-functional projects and managing complex quality investigations to effective closure.
- Strong, practical understanding of ISO 13485, FDA 21 CFR Part 820, EU MDR, and related global regulatory frameworks.
- Excellent problem-solving, judgment, and independent work skills.
- Outstanding stakeholder management, communication, and influencing abilities.
Preferred
- Hands-on experience with electronic Quality Management Systems (eQMS) and digital workflow tools.
- Familiarity with Generative AI (GenAI) applications in a quality or compliance context.
- Experience in mentoring junior QA staff or leading sub-functional quality initiatives.
Why Join ResMed?
At ResMed, we are united by our mission to improve the quality of life for millions suffering from sleep apnea, COPD, and other chronic diseases. Joining our team means more than just a job—it’s an opportunity to make a tangible difference in global health.
Our Culture & Benefits:
- Challenging & Inspiring Work: Tackle complex problems that directly impact patient outcomes and product excellence.
- Supportive Environment: Thrive in a culture driven by excellence, where we help you meet—and exceed—your professional goals.
- Innovation & Inclusion: We celebrate diverse perspectives and individual expression, believing this is the key to generating groundbreaking ideas.
- Career Growth: Discover a career path that is both demanding and rewarding, with opportunities for continuous learning and advancement.
If you are ready to lead quality system innovation and contribute to a healthier world, apply now for the Manager, Quality Systems role at ResMed.
We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer.
