Job Summary
Resmed’s products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. Resmed products are marketed based on a reputation of high quality. The Post Market Surveillance (PMS) team supports Resmed’s products sold to the global market and overall strategy to maintain quality, safety, cyber security, customer satisfaction and business ethics while supporting Resmed’s profitable growth.
The primary quality deliverable of The Complaint Handling Team, which forms part of The PMS Team, is the management of the complaint handling and vigilances processes, ensuring internal processes and systems are aligned to regulatory requirements and industry standards, while maintaining compliance and efficiency of complaint workflows.
Primary Position Objective
The Engineer – Product Complaints will have a solid understanding of the end-to-end complaint handling process, including regulatory requirements, risk management and root cause investigations.
This role serves as an interface point between the regional complaint handling teams and the investigation teams, contributing to consistent complaint handling and regulatory alignment across all Resmed markets.
Job Environment
The Product Quality Team supports products sold both in the region, and to the global market. They ensure Resmed’s regional stakeholders have the tools, processes and systems to provide service, support and management of quality issues with released products. The team is also responsible for identifying any adverse trends, ensuring appropriate clinical review and any need for further escalation.
Responsibilities
Pro-actively work with The Investigation Teams to determine the investigation pathway and prioritization of escalated complaints, including initiating containment actions and/or launching corrective actions based on risk and root cause, while ensuring alignment with global processes and regulatory expectations.
Drive the closure of escalated complaints, facilitating activities such as risk assessments, clinical opinions, product evaluations, root cause analysis, containment actions and corrective actions.
Provide regional complaints handling entities with adequate support and information to respond to customers. Make timely quality decisions, acting as an escalation point for emerging product quality issues in, including working with appropriate stakeholders to support the resolving of these issues through Resmed’s quality escalation process.
Coordination of upstream and downstream stakeholders, including Customer Service, Technical Service, Investigations and Regional Marketing and Commercial Teams to provide context and insight to escalated issues, and ensure consistent messaging across the region.
Participate in the preparation for audits, ensuring compliance and readiness. Support the maintenance of procedures in accordance with ResMed’s Quality Management System.
Position Specific Skills and Challenges
Efficient task management and correct prioritisation
Attention to detail Strong verbal and written communication skills Ability to make timely quality decisions, including escalation when appropriate and sharing relevant information with multi-region stakeholders
Strong understanding of international medical device complaint and vigilance requirements (e.g. FDA, EU MDR, Health Canada, ANVISA, TGA)
Independent self-direction and excellent organizational skills
Excellent problem solving and analytical skills
Qualifications and Experience
Required
Engineering or Science Degree or equivalent
3-5 years related experience with a medical device manufacturer
Experience with the end-to-end complaint handling process
Experience with vigilance reporting of medical device incidents to regulators
Preferred
Formal training in Quality Systems or Six Sigma
Experience in an ISO, MDSAP or EU MDR certified quality driven industry or equivalent experience
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!
