The Company This is an exciting opportunity to join an Australian owned Medical Device and Market Leader. Established for over 130 years you will be working with a small friendly and supportive team based in the South East Suburbs. The Role A new opportunity has become available for a Quality and Technical Engineer for a Permanent Position with an immediate start. $$ Attractive salary package on offer $$ 8-4pm Monday to Friday ( flexible with start and finish times) Working for a supportive team Great culture Are you looking for a design focus or a documentation focus engineering role? Do you have any background in: mechanics of materials, electronics & software design, mechanisms, biocompatibility, V&V testing & reports, creating risk assessments? Do you have any background with 3D solid modelling CAD software? Solidworks/Inventor/CATIA/NX etc. Do you have any background with producing engineering drawings & GD&T? Do you have any background with engineering change processes as part of ISO 9001 / ISO 13485? Key Duties will include: Ensure that products meet all technical specifications and quality standards, bridging the gap between development and compliance. Create and maintain accurate product documentation, including product requirements and risk assessments as well as work instructions, user manuals and technical manuals. Ensure that the technical file and design history file are kept up-to-date and compliant with industry standards. Manage the Engineering Change Notice (ECN) process, implementing the changes and ensure updates are reflected in all documents. Perform product verification to ensure that all product requirements are met. Provide technical support to internal teams and customers and identify process improvement opportunities. Technical responsibilities include: Product Design & Development Support, Technical Documentation, Verification and Validation (V&V), Process Validation, Implementation of Engineering Changes, Product Non-conformance investigation. Quality responsibilities include: Quality Management System Support, Inspection and Testing, CAPA and Root Cause Analysis Support Regulatory Compliance, Customer Complaint Investigation, Post-Market Surveillance, Cross Functional Collaboration To be successful: Previous industry experience ideally from the Medical device Industry, with a minimum of 3-4 years experience Qualified Electronics/Mechanical Engineer or related discipline. Previous experience with QMS (preferably ISO 13485) with Intermediate Word and Excel skills Previous experience producing engineering drawings in highly regarded Excellent technical documentation and report writing skills and an understanding of Risk Analysis. Are adaptable, flexible and a team player If you believe you fit the criteria please "apply now" and shortlisted candidates will be contacted shortly. Please ensure you submit your resume in Word Format.