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16

February

Senior Quality Assurance Engineer

ResMed - Sydney, NSW

Manufacturing & Industrial
Source: uWorkin

JOB DESCRIPTION

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

The primary role of the 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 customers’ quality requirements.

Our QA team is looking for a Senior Quality Engineer to support ResMed’s Product Development teams. This exciting opportunity will work with a global team of innovative engineers supporting hardware and software products.

In this role, you will work with cross-functional teams to ensure efficient quality system compliance, product that meets and exceeds customer expectations and drive process improvements and best practices.

Let’s talk about responsibilities:

Develop project Quality Plan to enable new product implementation or changes to released product in an efficient way that satisfies ResMed’s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), risk and project timing.

Advocate customer expectations for product quality and reliability, by providing effective, targeted and timely input to decisions. Also identify, evaluate and escalate risks that could impact product quality/reliability/field performance. Effectively communicate concerns and lead resolutions of product quality/reliability risks with Product Development, Quality Assurance, Regulatory Affairs and other stakeholders.

Review and evaluate quality risks associated with projects’ compliance. Recognise quality risks that require escalation. Effectively communicate concerns and lead resolutions of quality risks with stakeholders.

Review Product Development deliverables to ensure they are completed accurately and efficiently.

Manage or support the response to audit findings and CAPAs in the Product Development area.

Collaborate with other Quality and Regulatory team members to provide updates and support effective QA guidance to the project teams.

Actively identify process improvements in collaboration with the Development teams and other team members and drive implementation of changes with stakeholders.

Identify and provide or facilitate training of the Development teams. Topics may include ResMed’s processes and systems, Quality Systems requirements for medical devices, best quality practices, CAPA, root cause analysis, problem solving, quality risk assessment.

Lead the roll out and adoption of new quality processes or systems in Product Development.

Engage with Development and business stakeholders to build relationships to influence and drive quality considerations into key decisions.

For software only products – extend the above responsibilities to deployment and production support activities as they relate to the specific project.

Let’s talk about qualifications and experience:

To get us really excited, you will have a Bachelor’s degree in Engineering, Computer Science or Science (or equivalent), with 5 years of relevant experience in a Product Development environment.

You have a proven ability to interpret quality and regulatory requirements to “right-size” quality activities to meet compliance, business needs and risk.

We expect that you possess excellent communication and stakeholder management skills and are comfortable dealing with cross-functional teams from different levels. You demonstrate leadership and flexibility to work with the business to address quality risks and improvements.

In this role, you will need a strong understanding of medical device quality compliance requirements including ISO13485, ISO14971, FDA 21 CFR Part 820 and EU MDD/MDR. Preference will be given to candidates who also have experience in IEC62304 and different software development methodologies, e.g. Agile, DevOps.

#LI-MC1

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!

ResMed