Quality Systems Engineer

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

• Manage business Projects using a Project Management Framework and work with IT Squad using agile methodology to develop and maintain QA systems. This will include to managing priority, budget and resources for successful project implementation.

• The objective of CAPA and Projects specialization within Quality Assurance Job Family is to lead and implement significant projects and Corrective and Preventative Actions (CAPA), across the business, to create and improve quality and business processes.

• The CAPA process forms a cornerstone of our regulatory compliance activities. This team ensures that all CAPA (Corrective and Preventative Actions) investigations and reports meet the requirements of the business and external authorities (ISO, FDA etc.).

• Teams members lead projects with core team members from all ResMed functions involved in assigned projects and CAPA’s.

• Performs work in a specialized area of expertise that requires knowledge of fundamental themes, principles and concepts. Typically requires a university degree or equivalent work experience.

• Responsibilities might include:
  (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)

• Builds productive internal/external working relationships.

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

Let’s talk about Qualifications and Experience

• Bachelor’s degree.
• Minimum of 3 years of related experience.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

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!