Quality Engineer — Eight Mile Plains, Brisbane

Reporting to the Manager, Quality Assurance (QA), you will join a diverse group of experienced QA professionals to serve as the lead quality representative for WCA products within the production and post-market lifecycle phases. Provide ongoing support to the quality management system (QMS) in line with ISO 13485 and FDA’s 21 CFR Part 820 Perform activities within the QMS to ensure company quality objectives are achieved Lead and support the management of product/process non-conformances, including root cause analysis, risk assessment, escalation, disposition and identification of corrective actions Conduct risk-based decision making and effective resolution of issues which impact on production Facilitate, lead and collaborate with cross functional teams to improve QMS and manufacturing processes Provide quality support for change management including the review and approval of changes to medical device design, labelling, manufacturing, facilities, equipment, software and quality system processes Support the Corrective and Preventative Actions (CAPA) process as a CAPA assignee or CAPA sponsor Identify continuous improvement initiatives We are seeking people who align with our company values and have a passion for providing quality solutions to our patients. To be successful in this role, you will be able to demonstrate the following skills and experience: Tertiary qualification in a technically related field i.e. Science or Engineering essential Working knowledge of investigation methods and tools preferred Experience working within a highly regulated industry such as Medical Devices essential Knowledge of medical device regulations, including pertinent standards and guidance essential An understanding of quality control/assurance in a manufacturing environment essential Employee Benefits: Base salary plus performance-based quarterly bonus and annual leave loading Prioritise your physical and mental wellbeing with Employer paid BUPA Top Hospital health cover for you and your immediate family as well as discounted extras, access to onsite gym and our employee assistance program Subsidised cafeteria, wellness room, prayer room and onsite parking Ongoing support, mentoring and professional development Inclusive team culture with opportunities to join our community engagement initiatives About us: Since 1963, Cook Medical have been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities. At Cook Medical, we use our high ethical standards and core values to guide our decisions and actions. We approach innovation by first listening to understand and then creating a solution. Supporting a Diverse Workforce: We are proud of our diverse workforce and value individual contribution. We appreciate that every employee can add value to our organisation in their own unique way and want to ensure that our company culture stays balanced and strong. We encourage applications from Indigenous Australians, people with disability, those from diverse cultural backgrounds, people from the LGBTQI community, and anyone else who wants to be a part of our Cook Australia family. Community Commitment: Our community program seeks to have a positive, transforming impact on our people, the environment and our local community. The program has four pillars: Community Engagement: We support our local community through philanthropy, education and partnerships. Our employees have been at the forefront of these initiatives, and we’re proud of their contribution to making our community stronger. Environment and Sustainability: We are committed to being good stewards of the environment by aiming to ensure that our practices and processes are sustainable and responsible. Employee Engagement: We invest in our internal community through developing our employees, supporting their wellbeing and promoting an inclusive and diverse culture. Reconciliation: We’re exploring a pathway towards making a meaningful commitment to Reconciliation by strengthening our understanding and appreciation of Aboriginal and Torres Strait Islander peoples’ cultures, history and diversity. Learn more about us: Visit www.cookmedical.com.au/careers