Overview 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. Responsibilities Provide ongoing support to the quality management system (QMS) in line with ISO 13485 and FDA's 21 CFR Part 820Perform activities within the QMS to ensure company quality objectives are achievedLead and support the management of product/process non-conformances, including root cause analysis, risk assessment, escalation, disposition and identification of corrective actionsConduct risk-based decision making and effective resolution of issues which impact on productionFacilitate, lead and collaborate with cross functional teams to improve QMS and manufacturing processesProvide quality support for change management including the review and approval of changes to medical device design, labelling, manufacturing, facilities, equipment, software and quality system processesSupport the Corrective and Preventative Actions (CAPA) process as a CAPA assignee or CAPA sponsorIdentify continuous improvement initiatives Qualifications 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 essentialWorking knowledge of investigation methods and tools preferredExperience working within a highly regulated industry such as Medical Devices essentialKnowledge of medical device regulations, including pertinent standards and guidance essentialAn understanding of quality control/assurance in a manufacturing environment essential