World Leading Multinational Organisation
Working within a highly experienced Quality Assurance Team
Outstanding work environment including Top Hospital Cover and monthly bonus
COOK Medical, a global leader in interventional medicine, has sales, marketing and manufacturing offices worldwide. COOK is at the forefront of medical research and product development in minimally invasive health care devices. In an effort to support our continuing growth, we seek the services of a Quality Assurance Engineer on a permanent basis to join our team at our Australian head office located at Eight Mile Plains.
Cook as an Employer:
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a private corporation. The Australian Head Quarters is located in the Brisbane Technology Park, Eight Mile Plains, Queensland. Our manufacturing operation is steadily growing and manufacturing more complex devices for our global markets.
Cook Medical has over 10,000 employees worldwide, operates directly in 39 countries and delivers products to 135 countries around the world. Cook Medical consists of nine business units and produces over 7,000 different products for the global market. The future of medical care has never been more exciting.
For more information about Cook Medical, visit http://www.cookmedical.com
Cook Can Offer:
• An opportunity for you to join a company that is committed to improving medical care.
• Onsite subsidised cafeteria.
• A culture that supports personal growth and continuous learning.
Key Responsibilities include but are not limited to:
• Contribute to the processing and control of Quality Management System processes.
• Assist with the processing and management of the CAPA system including: provide technical support to CAPA assignees and sponsors; perform root cause analysis; create effective Corrective and Preventative Action Plans ensuring root causes have been eliminated; carry out CAPA verification activities to ensure effectiveness of actions taken.
• Provide technical support for non-conforming product/processes system, including evaluating final reports
• Provide quality engineering support to production and R&D.
• Timely evaluation and investigation of complaints relating to products manufactured by COOK Australia.
• Review and provide input into risk management documents and validation studies.
• Tertiary qualification in a technically related field i.e. Science, Engineering etc. is essential.
• Experience working within a highly regulated environment such as Medical Devices, Pharmaceuticals or Biotech preferred.
• An understanding of quality control / assurance in a manufacturing environment is essential.
• Experience in project management is desirable.
• Highly developed employee engagement skills and the ability to influence others.
• Ability to communicate effectively with people at all levels of the organisation.
• Analytical approach to problem solving with the ability to identify and implement appropriate solutions.
• Microsoft Office skills.
• Ability to manage competing priorities.
• Ability to convey technical information in writing.
• Ability to work effectively both independently and in a team environment.