ResMed
Graduate Engineer – Quality Assurance (QA) – Product Development (FTC 6-Month)
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.
Job Description Summary:
At ResMed, we pride ourselves on producing high-quality medical devices that meet rigorous regulatory requirements. As a Graduate Engineer in our Quality Assurance (QA) department, you will play a crucial role in supporting the design, development, and delivery of products that meet both customer expectations and regulatory standards. You will help ensure that ResMed products are reliable, meet high-quality standards, and comply with industry regulations across various markets.
Key Responsibilities:
Support Project QA Planning: Assist in the development and implementation of project QA plans to ensure that new product implementations or changes to existing products are conducted efficiently, meeting ResMed’s Quality System, regulatory requirements (e.g., ISO13485, CFR820, MDSAP), risk management protocols, and project timelines.
Quality & Reliability Advocacy: Advocate for product quality and reliability by assisting with the timely and effective input into decision-making processes. Identify, evaluate, and escalate potential risks that could impact product quality or field performance. Collaborate with cross-functional teams, QA, Regulatory Affairs, and other stakeholders to address and resolve these risks.
Product Development Deliverables: Assist in reviewing product development deliverables to ensure they are completed accurately, efficiently, and in compliance with quality standards and regulatory guidelines.
Audit Support & CAPA: Support the response to audit findings and assist in the management of Corrective and Preventive Actions (CAPAs) within the Product Development area.
Collaboration & Guidance: Work closely with Post-Market Quality, QA Production, and Regulatory teams to provide necessary updates and ensure that effective QA guidance is provided to project teams.
Process Improvement Initiatives: Identify opportunities for process improvements within the scope of the project. Collaborate with Development teams and other QA team members to drive and implement these improvements.
Qualifications and Experience:
A recent graduate with a degree in Engineering, Computer Science, Science, or other related fields relevant to the position.
Strong analytical and problem-solving skills, with the ability to work collaboratively in a cross-functional team environment.
A keen interest in quality assurance, regulatory compliance, and medical device development.
Skills & Competencies:
Attention to detail and strong organizational skills.
Effective communication skills and the ability to present ideas clearly.
Ability to manage multiple tasks simultaneously and meet project deadlines.
Why Join Us?
This is a great opportunity for a graduate engineer to start their career in the medical device industry with ResMed. You will be involved in high-impact projects, contributing to the development of innovative products that make a difference in the lives of patients. We offer a dynamic and supportive work environment where you can grow professionally and develop your skills in the field of quality assurance and product development.
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!
