Job description
The Director or Manager for the Quality Management Systems will manage, resource and continuously improve systems in Sydney and Singapore and integrate global processes.
As part of the Regulatory Affairs and Quality Assurance team located in Sydney this role is intergrel to ensure that management systems are established to enable compliance with multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements.
Responsibilities include:
Extend, manage and maintain the structure, governance and integrity of the Global Quality Management System and ensure compliance with the requirements and intent of the applicable regulatory standards
Partner with Global Business Process Owners to assist continuous improvement of processes and implement strategies for the continual development of the quality system based on world’s best practice and analysis of specific needs
Partner with business owners to understand existing and emerging needs, develop strategies and tactics to ensure systems are aligned and supportive
Maintain an effective global policy framework to support changing business needs
Working with key business partners and regional quality representatives to optimise integration of new entities into the Quality Management System and assist them to adapt to local business needs
Working with IT and other key stakeholders optimise IT systems and infrastructure to support and extend capabilities and functionality of infrastructures, tools and processes
Establish metrics and feedback mechanisms to monitor continued effectiveness of the systems to business and regulatory needs
Manage Quality Assurance related projects to meet customer requirements, timing and budgets
Lead and coordinate the activities of a team to meet project objectives including the resources across multiple projects in line with overall business strategy and stakeholder priorities
Operate as part of the regional and global Quality Leadership Team to develop and implement a cohesive quality strategy for the business
Build strong networks and work with teams in other parts of the business to ensure that systems are in alignment and suitable for global deployment where appropriate
Desired Skills and Experience
You will be Degree qualified with a number of years experience in Quality or Engineering Management positions in an ISO certified quality driven industry, ideally in roles with a global component.
Any experience in the medical device industry and with FDA audits will be looked upon favourably.
Communication and innovation are keys to success in this role, you will have highly developed skills in stakeholder liaison and enjoy building positive working relationships across the business.
