Senior Quality Assurance Associate

Our Story

4DMedical is a global medical technology company aiming to change the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. Our vision is a world in which people with lung disease have better health outcomes.

We are listed on the ASX and we are currently in a high-growth stage of the business.

What can you expect as a Senior Quality Assurance Associate

As part of our high achieving Quality Assurance team this role will primarily be responsible for the preparation, execution, maintenance, and tracking of quality assurance documents and files (including updating the QMS), as well as ensuring company compliance to Quality Management System processes.  This role will support internal stakeholders (such as product teams) to understand the QMS and assisting them with product releases, as well as driving Nonconformances and CAPA to completion.

The role will include, but is not limited to:

• Assist in training team and staff members on the function and use of the Quality Management System, relevant internal and external global quality standards, policies, procedures and requirements.
• Preparation, collation and maintenance of medical device quality documentation ensuring compliance with health authority/ notified body requirements and relevant Australian and International standards.
• Maintain and update product risk management files, including risk management reports, as per ISO 14971 to ensure it accurately reflects current device risks and controls throughout the product lifecycle.
• Raising, co-ordinating, processing and approving changes and Change Orders, as applicable.
• Assist with Product Releases including reviewing applicable documentation and ensuring software releases are compliant to required processes including ISO 62304.
• Responsible for identifying and ensuring non-conformances, and CAPA and Customer Complaints are appropriately escalated and completed.
• Mentoring and directing Quality Assurance Associates where required, in aspects of the Quality Management System.

  Qualifications & Industry experience requirement:

• >3 years working in the medical devices pharmaceutical or biotechnology industries in Quality or Regulatory Role.
• A strong working knowledge of ISO 13485 &/or FDA 21 CFR Part 820 regulations. Other quality standards related to the essential principles/requirements is ideal.
• Ability to work with complex technical documentation, write effective processes, & competently utilise work applications (e.g. MS Word, MS Excel, etc).
• Experience of product releases and regulatory submissions preferred.
• Mentoring or coaching experience of other Quality Associates desirable.
• Tertiary qualified, preferably in a science-related discipline (e.g. sciences, engineering, etc).

This is a fantastic opportunity for anyone who enjoys working in a fast paced, friendly and collaborative environment.

What can we offer you?

• Hybrid working – when in the office enjoy our amazing new office space which includes end of trip facilities, and great local coffee and eateries!
• Easy access to Public Transport and very close to Lygon St and the CBD
• Frequent in-house presentations on all aspects of Lung Health & Technology.
• Bonus annual leave scheme as well as company paid Parental leave.
• Be a part of our Wellness program including free fruit, table tennis, free gym and corporate class pass, Employee Assistance Program for you and your family, free annual health, free skin check & free flu shot.
• Rewards and Recognition Program including discounts for shopping and goods.
• Laptop and accessories provided for remote work
• Regular social events

An opportunity for you to grow in a friendly and supportive culture

How to Apply

Please apply via this link https://4dmedical.bamboohr.com/careers/90?source=aWQ9MjI%3D and submit a current CV and a cover letter that details your alignment with the requirements of the role.

4DMedical provides an inclusive work environment and embraces the diverse talent of its people.

For more company information visit our website: www.4dmedical.com

Should you have any queries regarding the position please contact the 4DMedical Recruitment Team at: [email protected]