Do you have a practical understanding of medical device quality systems? Are you excited about applying your quality system knowledge to an innovative AI/ML-based Software as a Medical Device? If this is the challenge you’ve been looking for, we would love for you to join our journey to make a difference to the lives of people who need joint replacement surgery!
About the business
Formus Labs is developing groundbreaking software solutions to improve joint replacement surgery. Our cloud-based platform is a world-first in employing state-of-the-art biomechanics and AI to help surgeons create optimal surgical plans for each individual patient. Our technology has already empowered surgeons and global orthopaedic companies to provide best-in-class joint-replacement surgery to hundreds of patients.
Spun out from the world-renowned Auckland Bioengineering Institute, we are a dynamic startup with a highly talented team from a diverse set of backgrounds. Our brand new office is located in the CBD fringe and we have an excellent hybrid working environment.
We have an ISO 13485 certified Quality Management System for a software product. Our first product, Formus Hip, is an AI/ML-based Software as a Medical Device with market authorisations in Australia and New Zealand, with US FDA 510(k) in progress.
About The Opportunity
We are looking for an Auckland-based Quality System Engineer to support the execution of all aspects of the QMS to ensure that all processes meet internal and external requirements. You will be involved in all areas of the QMS, including but not limited to managing CAPAs, customer complaints, supplier management, quality audits and supporting software development activities from a quality perspective.
- Support maintenance of the QMS to ensure compliance with global regulations and standards, including but not limited to ISO 13485 and FDA CFR 820
- Support and manage the CAPA system
- Support validation activities relating to computer software assurance
- Support quality audits by participating in audits and resolving any findings
- Manage the document control and training systems
- Support design control activities (including risk management) during software development to ensure quality requirements are met
- Support post-market activities (such as, complaint handling)
- Support continuous improvement efforts across the QMS
Need to have:
- A minimum of 3-5 years hands-on experience within the medical device industry
- Practical understanding of a QMS per ISO 13485 and FDA CFR 820
- Experience in managing critical aspects of the QMS, such as CAPAs and complaints
- Good understanding of design controls and risk management
- Excellent oral and written communication and the ability to effectively communicate throughout the organisation
- Excellent interpersonal skills and a desire to engage and learn from others as well
- Strong organisation skills and attention to detail
Helpful to have:
- Experience with applying medical device quality system requirements to a Software as a Medical Device
- Understanding of software development lifecycle process per IEC 62304
- Understanding of Agile development practices as they relate to medical software development
- A passion for software technology in the medical device field and familiarity with various computerised systems