Quality Testing and Validations Engineer — Lane Cove West, Lane Cove Area
Expired

About Sabre Medical Pty Ltd: Working with an innovative company across a range of medical device technologies. The company is expanding to bring to market a new medical device technology and integrate this production within our cleanrooms in Sydney, Australia. As an accredited company to ISO 13485, there is a continual development investing into new technologies that will manufacture medical devices. This is a role where the right person will enjoy being able to work across a range of evolving technologies both locally and from Europe. Responsibilities: Manage the testing facilities and validation of test methods and test equipment. Develop testing protocols, testing schedules and reports. Manage the entire process from acceptance of test articles to invoicing and report dispatch. Maintain compliance with current standards and industry practices of testing. Communicate with customers to provide clear descriptions of test protocols and accurate quotations. Establish risk assessments and mitigation for processes related to testing and quality control. Assist the quality manager with the acknowledgement of customer feedback and completion of NC-CAPA reports Analyse data metrics for determination of quality improvements Facilitate the introduction of products and processes in the Sabre cleanroom Perform testing, cleanroom, and distribution operations as required. Experience and Qualifications: At least bachelor's degree in material science or equivalent, Proven 2-3 years' experience in Quality Testing and Validations, Good written and verbal communication skills and attention to detail for writing certificates and reports that are issued to customers, Competent with MS word, excel and outlook, Understanding of OH&S requirements Experienced with identification and implementation of risk management pFMEAs Understanding of CAPA processes, root cause analysis, cleanroom and device manufacturing standards, test methods to meet c GMP, FDA or CE mark etc. Proactive approach to ensuring the activities performed by others are in line with SOPs.

Applications close Sunday, 4 February 2024
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