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April

Global Quality Engineer, Customer Complaints

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.

Permanent / Full-time role

Located at either Sydney or Singapore

We are currently seeking applications from a Quality Assurance Engineer to join our Post Market Quality team located in Sydney or Singapore.

The Post Market Quality team supports ResMed’s released medical device products with complaint handling, engineering investigation, service tools, product analytics and technical support. The global complaints team ensures effective and compliant post market surveillance in the areas of complaint handling and vigilance reporting.

Let's talk about Responsibilities

ResMed’s products have earned the reputation of high quality standards for workmanship, performance and reliability. This role is responsible for reviewing initial customer feedback and ensuring that complaints are correctly escalated for further risk assessment, investigation, vigilance and compliance with internal and global regulatory requirements. The responsibilities include but not limited to –

Identify complaints that require further escalation or investigation. Working with other ResMed personnel globally to ensure customer complaint information is captured in the complaint handling system.

Work with global and regional complaint handling teams to meet regulatory requirements for product complaints, understand priorities and resolve customer issues.

Monitor complaints and customer feedback to check for appropriate escalation for further risk assessment and investigation and ensuring accurate and complete complaint records.

Prepare regular reports on the complaint intake and initial escalation process, as required for stakeholders.

Uses quality system software to manage complaints.

Creation and drafting of vigilance reports

Make timely quality decisions including escalating to management whenever appropriate and sharing relevant complaints and quality information with multi-region stakeholders

Understand the global timeliness requirements for processing of customer complaints

This role will also be responsible for staff training in complaint investigation policy and procedures, as well as regional regulatory reporting to ensure compliance with regulations and policy guidelines.

Let’s talk about Qualifications and Experience

To be successful in this role, you must be detail-oriented with superior problem solving and analytical skills to enable you to critically analyse systems and investigation results. You will also need to have –

Completed a Bachelor’s degree in Engineering or relevant Science degree or equivalent

With 2-5 years experience managing the complaint handling process operating in a highly regulated environment, preferably within a medical device or pharmaceutical industry

Knowledgeable of the Food and Drug Administration (FDA), Medical Device Regulation (MDR) requirements and applicable international standards such as ISO 13485

Experience using TrackWise Quality Management System, is an advantage

Strong verbal and written communication skills, with the ability to be highly organised

#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