Direct message the job poster from Cyclomedica
We are Cyclomedica – bringing light into nuclear imaging since ****. 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:***** 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 Role
We are seeking an experienced Quality Associate to join our qualified 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 Responsibilities
Creation, review and approval of controlled documentation - assist in development and implementation of quality systems including writing, and review, of procedures and work instructions and training
Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements
Preparation of Product Quality Reviews
Investigation and management of non-conformances, CAPAs, deviations and complaints
Assistance with audit findings and audit management




Cross-functional support of design and manufacturing and including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etc
Conduct of other routine QA duties such as issue and review of batch documentation, incoming and finished goods release
Plan and execute assigned process improvement projects
Required Skills and Experience
University degree in Science, Engineering or equivalent
At least four years' experience in GMP within Pharmaceuticals, Medical Devices or related field
At least two years' experience in a QA role
High level of verbal and written communication and numeracy skills
Thorough knowledge of standards and governing bodies
Excellent problem-solving skills
Proficient attention to detail, excellent written and verbal communication skills
Ability to work as part of a team
Why 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 package
Professional development opportunities
Health and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membership
Be part of an inspired and talented leadership team
Company culture that values respect, collaboration, innovation and ethics
You 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 level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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📌 Senior Quality Associate (Sydney)
🏢 Cyclomedica
📍 Sydney