Job Title

Direct message the job poster from CyclomedicaWe are Cyclomedica bringing light into nuclear imaging since 1986. We have paved the way with nuclear medicine solutions in Australia and around the globe. From innovation, development to clinical practice applications we are the world leaders in functional lung ventilation imaging with our proprietary technology: Technegas.Created and manufactured in Australia our flagship product Technegas has revolutionised diagnostic lung imaging and today transform the lives of millions of patients in 66 countries around the world.The site is FDA licenced for drug and device manufacturing and holds a TGA cGMP certificate as well as ISO:13485 certificate for the manufacture of its own CE marked Class IIb /IIa medical devices.Join us as we continue to shape the future of nuclear medicine.About the RoleWe are seeking an experienced Quality Associate to join our professional and committed team. Reporting to the Head of Quality, this role is primarily responsible for supporting the management of the medical device / pharmaceutical Quality Management System ensuring continued compliance with the relevant regulations, guidelines and industry standards.This is an on-site role.Key ResponsibilitiesCreation, review and approval of controlled documentation - assist in development and implementation of quality systems including writing, and review, of procedures and work instructions and trainingReview and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirementsPreparation of Product Quality ReviewsInvestigation and management of non-conformances, CAPAs, deviations and complaintsAssistance with audit findings and audit managementCross-functional support of design and manufacturing and including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etcConduct of other routine QA duties such as issue and review of batch documentation, incoming and finished goods releasePlan and execute assigned process improvement projectsRequired Skills and ExperienceUniversity degree in Science, Engineering or equivalentAt least four years experience in GMP within Pharmaceuticals, Medical Devices or related fieldAt least two years experience in a QA roleHigh level of verbal and written communication and numeracy skillsThorough knowledge of standards and governing bodiesExcellent problem-solving skillsProficient attention to detail, excellent written and verbal communication skillsAbility to work as part of a teamWhy Join Our Team?Rare opportunity to join a company that manufactures both drug and medical device with exposure to FDA, TGA and European Notified Bodies.Competitive and attractive salary packageProfessional development opportunitiesHealth and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membershipBe part of an inspired and talented leadership teamCompany culture that values respect, collaboration, innovation and ethicsYou will be joining an organisation that embraces diversity & inclusion.We are committed to providing products, services and solutions that improve clinical outcomes everyday. If you feel the same we would welcome your application!Seniority levelAssociateEmployment typeFull-timeJob functionQuality AssuranceIndustriesMedical Equipment Manufacturing #J-18808-Ljbffr