QA Manager

About Toll Group

At Toll, we do more than just logistics - we move the businesses that move the world. Our 16,000 team members can help solve any logistics, transport, or supply chain challenge - big or small. We have been supporting our customers for more than 130 years. Today, we support more than 20,000 customers worldwide with 500 sites in 27 markets, and a forwarding network spanning 150 countries. We are proudly part of Japan Post —

Quality Assurance Manager - Medical Devices

Global Logistics provides sophisticated supply chain solutions, from end-to-end or part solutions, warehousing and distribution to dedicated transport solutions, across the globe and to some of the most remote corners of the world.

Our customers produce goods from various parts of the healthcare ecosystem. From consumer healthcare products such as vitamins to medical devices including items such as contact lenses and robotic surgical instruments.

Toll has built expertise and has gained certifications to insure the safe movement and storage of all types of pharmaceutical and healthcare products.

In addition, within our specialised purpose-built facilities, our teams can manage repacking activities to meet our customer’s needs. rooms.

The Role

The Quality Assurance Manager, Medical Devices is to ensure compliance with ISO 9001 and ISO13485 standards for Toll Healthcare’s services at Device Technologies (DT) business in Marsden Park, NSW where Toll is responsible for all storage and distribution.

Your expertise will be called upon by the National Quality Manager to support activities at other Toll Healthcare sites to deliver the Toll Healthcare business initiatives.

You will display leadership to collaboratively achieve optimum performance with respect to Quality and GMP issues. You will require initiative to identify, develop and implement cost effective, optimal solutions for operational and quality improvements. A full understanding of the Toll activities will require you to be hands-on to ensure initiatives are operationally practical and deliver the agreed customer’s requirements.

Your understanding that Quality Compliance is a journey and not a destination is crucial in guiding and mentoring staff to see that continuous improvement initiatives, developed and initiated by you, are essential for the business to remain competitive.

As the senior Quality person on-site at DT, you will be the primary contact for DT with respect to Quality Assurance. This will include a level of customer service duties or functions that support the Marsden Park operation generally. You will be supported in this role by the National Quality Manager and the Healthcare Quality team based at other sites.

As a Quality Assurance Manager - Medical Devices you will:
Lead Quality Assurance initiatives, ensure regulatory compliance, manage Quality Systems, implement risk management, drive continuous improvement, conduct audits, and oversee supplier quality management. Support the national quality strategy for medical device logistics, prepare quality performance reports, mentor staff on quality ideologies, and foster a culture of excellence and continuous improvement. Design and develop Q.A & Q.C policies and procedures, implement compliance metrics, and contribute to effectiveness checks to ensure adherence to healthcare regulations and continuous improvement. Conduct internal inspections, evaluate data for Q.A & Q.C initiatives, identify and implement corrective actions, and collaborate with service providers to enhance service quality and ensure regulatory compliance. Develop and evaluate training programs, mentor Operational and Quality staff, and support the National Quality Manager in managing customer and supplier contracts to ensure quality agreement activities are delivered effectively. Extensive expertise in regulatory compliance with a focus on ISO13485 but also with ISO9001, GDP, and PIC/S as applied to healthcare logistics life cycle management. Expertise in Quality Management Systems (QMS), audit processes, data analysis, continuous improvement methodologies (Lean, Six Sigma, Kaizen), and training program development and delivery would be well regarded.

About you:
To be successful in this role, you will need:

- Educational Background: Minimum Bachelor's degree in Engineering, Life Sciences, or a related field. An advanced degree (Masters or Ph.D.) is desirable.
- A minimum of 7 to 10 years' experience in quality assurance or quality management within the pharmaceutical or medical device industry, with at least 3 years in a leadership role.
- Expertise in implementing and managing ISO13485 compliant quality systems within in a manufacturing operation or direct involvement in a PIC/s regulated environment and the understanding of the difference between these quality systems.
- Strong knowledge and understanding of warehousing and distribution practices, including the operations of a global 3PL Healthcare company. Background in tra