Join an organisation that is committed to quality and patient outcomes
Permanent position located at Eight Mile Plains
Access to generous employee benefits
We are seeking the services of a dedicated Manufacturing Engineering Team Leader to join our Manufacturing Engineering team in our Australian Head Office at Eight Mile Plains.
About this role:
Reporting to the Manufacturing Engineering Manager, this role focuses on the compliance of Cook Australia’s manufacturing processes with global regulatory requirements for validation, calibration, and process monitoring and control. In this role you will implement industry best practice in the management of critical manufacturing processes to assure the quality of Class 2 and 3 medical devices. You will develop team goals to meet business needs and manage team resources to ensure their completion on time and in budget. You will also be responsible for the ongoing development of the Validation and Calibration team members. This is an opportunity for you to demonstrate strong leadership within a global medical device manufacturer.
• Lead the Validation and Calibration team within the Manufacturing Engineering Group.
• Develop and implement best practice validation, calibration and process monitoring practices and procedures.
• Identify training and development requirements within the team and ensure training is completed as required.
• Define and communicate the roles, priorities, responsibilities and expectations of the team.
• Manage relevant team projects to ensure completion is on time, budget, and achieves its forecast goals.
• Ensure compliance with Cook values, quality system procedures, policies, and relevant medical device standards and regulations.
• Experience with process validation essential (medical device industry or similar).
• Experience working within ISO 13485 or similar quality management system essential.
• Demonstrated experience in implementing change to drive best practice essential.
• Demonstrated strong leadership skills and experience essential.
• Experience applying process risk management techniques in developing process monitoring plans desirable.
• Technical experience with various manufacturing processes including washing/drying, packaging, and bonding desirable.
• Experience with FDA 21 CFR part 11 desirable.
• Intermediate level statistical data analysis skills desirable.
To be eligible to apply to this role, applicants must be a permanent resident or citizen of Australia, with full working rights.
Cook can offer:
• An opportunity for you to join a company who is committed to improving medical care
• An attractive package including monthly bonus and Private Hospital Cover for all employees
• A culture that supports personal growth and continuous learning
Cook as an Employer:
Cook Medical is the largest privately owned Medical Manufacturing Company in the world with the Head Office located in Bloomington, Indiana. COOK employs over 10,000 staff worldwide, together they create, manufacture and sell minimally invasive medical devices.
The future of medical care has never been more exciting.
If you would like to know more about Cook Medical please visit http://www.cookmedical.com
If you are interested in joining the Cook Medical family and possess all the requirements above, please click on the “apply now” button below.