The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. Key deliverables include creating and building relationships with medical device regulatory in every country. Ensure timely registration to meet business needs. Also, responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. Capability and process development for compliance and Continuous improvement. Global responsibility for QMS alignment across global quality systems. Maintenance and security of documentation system and record keeping.

Let’s talk about Responsibilities

• The primary objective of QA Engineering specialization within Quality Assurance Job Family is to design, implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.

• Mentor, train, and support team members to enhance quality awareness, skills, and performance.

• Support the Distribution team in achieving optimal outcomes in quality, delivery, cost targets, and engaging in continuous improvement activities.

• Occasionally leads the work of project teams and might formally train junior staff.

• Develop, implement, and maintain Standard Operating Procedures (SOPs) and quality systems in alignment with industry regulations (ISO 13485, MDSAP, 21 CFR Part 820).

• Oversee regulatory compliance audits and serve as a key liaison with internal stakeholders.

• End to end management of NCP and CAPA processes across sites and any local on-hold process-related actions.

• Maintaining knowledge of the company’s Quality Management System (QMS) to ensure

• Manage quality projects, managing resources, timelines, and deliverables to achieve impactful results.

• Provide accurate, factual, and timely updates on quality metrics, audit findings, and improvement initiatives.

• Prepare reports for leadership on quality performance, project progress.

• Communicate changes in policies, processes, and quality standards clearly to internal and external stakeholders.

• Present quality performance metrics, audit findings, and project updates to leadership and cross-functional teams.

• Act as a trusted advisor to build trust and open relationships with stakeholders across organizations to enhance team effectiveness.

• Lead or facilitate process improvement/standardization initiatives with wide range of teams with broad ranges of experience in formal process development.

• (1) Performing routine professional-based activities (early in career)
  
  (2) Contributing to and managing projects (mid-career)
  
  (3) Providing advice/direction in primary areas of expertise (specialist and expert)
  
  (4) Leveraging professional expertise and relationships to contribute to strategy and drive business results (principal)relationships to contribute to strategy and drive business results (principal)

Let’s talk about Qualifications and Experience

• Bachelor’s degree in Engineering, Manufacturing Engineering, Quality Management, Compliance, or related field.

• 1+ years of experience in quality assurance/control within a manufacturing or distribution environment.

• Expertise in regulatory compliance, process validation, and quality system management (ISO 13485, MDSAP, 21 CFR Part 820).

• Strong interpersonal, relationship-building, and communication skills.

• Self-motivated, with a demonstrated ability to work independently and drive impactful results.

Preferred:

• Experience in change management and process improvement.

• Knowledge of structured problem-solving techniques (e.g., A3, DMAIC, 8D).

• Familiarity with quality systems within a global or regional distribution environment.

• Excellent written and oral communication and negotiating skills. 

• Strong multitasking skills with the ability to prioritize to the business needs.

Work Environment Preferred:

• Role primarily based in an operations/warehouse environment with occasional travel (up to 10%).

• Physical requirements include walking, standing, sitting, and occasional lifting (up to 50 pounds).

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and 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), and tuition assistance.

$80,000-$119,000

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!