• Global Organisation specialising in interventional medicine
• Working within a highly experienced Quality Assurance Team
• Outstanding Staff Benefits including Top Hospital Private Health Cover
COOK Medical, a global organisation specialising 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 Post Market Quality Specialist to join our team in our Australian Head Office at Eight Mile Plains, Brisbane. The Post Market Quality Specialist is responsible for the quality processing and analysis of post market quality data (e.g. complaints, adverse events and field actions).
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.
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
Please note, candidates applying to this role must be a permanent resident or citizen of Australia with full working rights.
Key Responsibilities include but are not limited to:
• Develop and implement tracking tools / reports to monitor metrics and trends.
• Collect, review, track, trend, analyse and report on complaint data generated from the complaint handling system to create periodic reports.
• Drive identification of complaint trends and signals.
• Execute post market product data analysis to provide information on field product quality.
• Support post market surveillance reporting activities.
• Generate complaint reports to support business needs.
• Review complaint records for accuracy and completeness.
• Analyse complaint information for reportability and prepare reports to regulators.
• Assist with field action execution, reconciliation and data analysis.
• Assist with complaint administration tasks as required.
• Bachelor’s Degree in related field or experience of such kind and amount as to provide a comparable background Is essential.
• Experience working within a highly regulated environment such as Medical Devices is desirable.
• Intermediate Microsoft Office proficiency Excel, Word, PowerPoint) is essential.
• Knowledge of quality system standards (e.g. ISO 9001, ISO 13485, GMP) is desirable.
• Knowledge of relevant regulatory requirements for Australia, USA and EU is desirable.
• Highly organised with a focus on attention to detail.
• Ability to interact effectively with internal and external stakeholders at all levels and functions across the business.
• Highly developed communication and interpersonal skills.
• Results-orientated, with a high drive to meet personal objectives and standards of excellence.