COOK Medical, a global manufacturer of medical devices, 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 Lead Quality Auditor to join our team in our Australian Head Office at Eight Mile Plains, Brisbane.
The Lead Quality Auditor is responsible for the continued development, improvement, implementation and compliance of the Quality Auditing Systems at Cook Australia. This role also provides support and guidance to all Manufacturing, Quality and R&D activities to ensure compliance to regulatory requirements and company procedures.
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.
• An attractive package including monthly bonus and Private Top Hospital Cover for all employees.
• A culture that supports personal growth and continuous learning.
Key Responsibilities include but are not limited to:
• Develop and implement the Internal Quality Audit (IQA) system at Cook Australia to ensure compliance of the Quality Management System (QMS) with ISO13485, FDA QSR 21 CFR 820 and global standards as necessary.
• Manage and lead IQAs as necessary to ensure compliance of the QMS:
a) Create and maintain an internal audit plan based on defined inputs.
b) Conduct internal audits as detailed by the plan.
c) Follow-up of the implementation and effectiveness of the corrective actions identified during the internal audits
d) Report and communicate audit findings.
e) Develop and report relevant internal and external audit metrics.
• Audit domestic and international external suppliers affecting Cook Medical global operations as necessary.
• Provide support for regulatory and customer audits that concern the Cook Australia quality system.
• Provide auditor training, mentoring and support for Cook Australia staff as necessary.
• Contribute to the processing and control of Quality Management System processes as necessary, including but not limited to the corrective and preventative action (CAPA) system, the non-conformance (NCR) system and the complaint management system.
• Review and provide input into risk management documents and validation studies.
• Actively participate in process improvement and continuous improvement activities across the business.
• Tertiary qualification in a technically related field i.e. Science, Engineering etc. is essential.
• Demonstrated experience working within a highly regulated environment such as Medical Devices or pharmaceuticals preferred.
• Highly developed auditing skills are essential.
• An understanding of quality control / assurance in a manufacturing environment is essential.
• Intermediate Microsoft Office proficiency (Excel, Word, PowerPoint) essential.
• Ability to communicate effectively with people at all levels of the organisation.
• Highly organised with a focus on attention to detail.
• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards.
Please note, applicants applying to this position must have full working rights within Australia and possess the relevant visa.