Engineer - Complaints
2 days ago
Engineer – Complaints Role at Resmed Join to apply for the Engineer - Complaints role at Resmed. 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. 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. Responsibilities Pro‐actively work with the Investigation Teams to determine the investigation pathway and prioritisation of escalated complaints, including initiating containment actions and launching corrective actions based on risk and root cause. 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 and act as an escalation point for emerging product quality issues. Coordinate 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 audit preparation, ensuring compliance and readiness. Support 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 and share relevant information with multi‐region stakeholders. Strong understanding of international medical device complaint and vigilance requirements (FDA, EU MDR, Health Canada, ANVISA, TGA). Independent self‐direction and excellent organisational skills. Excellent problem‐solving and analytical skills. Qualifications and Experience Engineering or Science Degree or equivalent. 3–5 years of 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. About Resmed 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. Our culture is driven by excellence, and we focus on creating a diverse and inclusive environment, encouraging individual expression and thriving on innovative ideas. Benefits We provide a supportive work environment, competitive compensation, and opportunities for professional growth. Application Apply now to become part of Resmed. #J-18808-Ljbffr
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