About Us
We 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 more than 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.
About the role
We are seeking a talented Supplier Quality Engineer to join our professional and committed team. Reporting to the Head of Quality, this role is primarily responsible for leading the Supplier Quality Management process at Cyclomedica by managing suppliers and ensuring purchased materials are conforming to applicable requirements. This position will also be responsible for Cyclomedica's Approved Supplier List including evaluating and qualifying new suppliers.
Please note this is an onsite role – 5 days per week.
Key Responsibilities
• Effectively partner with suppliers in product performance, risk mitigation and continuous improvement.
• Lead and manage Supplier Non-Conformances to ensure corrective actions are addressed for all product performance issues.
• Conduct supplier audits to drive process standardisation, and continuous improvement.
• Participate in supplier approval process (questionnaires, risk assessment, audit, qualification, etc.).
• Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformances.
• Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Assist with audit findings and audit management.
• May specialise in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Interstate travel may be required to complete supplier audits.
Skills and Experience
• University degree in Science, Engineering or equivalent
• At least three years' experience in GMP within Pharmaceuticals, Medical Devices or related field
• At least two years' experience in a role that involves Supplier Management
• 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