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 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
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 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
#J-18808-Ljbffr