Quality assurance coordinator
About Australia & New Zealand
Our growing team of 1200+ employees work together to deliver world-class science products and solutions to a wide range of key markets. With commercial, manufacturing and distribution sites across Australia and New Zealand, including Melbourne, Brisbane, Sydney, Auckland, Adelaide, Newcastle, and Perth, our scope covers life sciences; specialty diagnostics; food, dairy & beverage; environmental & industrial; healthcare and analytical instruments including commercial, customer service, technical service, supply chain, finance and operations.
How will you make an impact?
From supporting Thermo Fisher Scientific ANZ Quality and Regulatory Systems and practices. The Quality Asurance Coordinator will play an integral role in supporting our mission to guide, partner, safeguard and embed Quality and Regulatory practices throughout the ANZ business.
What will you do?
- Assist QA team members to deliver a QA program based on the requirements of ISO 9001:2015 for Thermo Fisher Scientific Australia and New Zealand.
- Coordinate product fault reporting, acting as a critical pivot point as you liaise with multiple business units (including Customer Care, Logistics, Supply Chain, Warehouse, Manufacturers, Service, Product Management, Quality & Regulatory, and more).
- Support the coordination of chemicals licenses and permits and other aspects of global trade compliance.
- Coordinate the management of documentation and records (including Safety Data Sheets).
- Assist QA team members to deliver a strong continuous improvement system (including aspects of working with different business units on appropriate root cause analysis and Corrective and Preventative Action).
- Coordinate reporting and quality trend analysis.
- Coordinate aspects of supplier quality management.
- Be a member of the internal audit team.
- Assist RA team members in executing product recall activities.
- Assist RA team members in the formation and governance of material master. data as products are launched and manufacturers make changes.
- Be an advisor to the business on commonly used standards (such as ISO 9001) and aspects of regulation you have been trained against.
- Assist RA team members in product change control management.
- Play an active role in Quality and Regulatory project activities.
- How will you get here?
- Bachelor’s Degree (or equivalent) in a Business or Scientific discipline
- Strong knowledge of, and experience with, ISO 9001:2015. Knowledge and experience with ISO 13485:2016, ISO 17025:2017, import and export permits, global trade compliance and/or chemicals would be highly regarded.
- Internal auditor qualifications would be highly regarded.
- Experience mapping processes and workflows would be highly regarded.
- Knowledge of medical devices, life sciences, industrial, scientific equipment would be highly regarded.
- Experience in Regulatory Affairs is not essential, however would be highly regarded.