Quality System Lead
Do you consider yourself a nimble navigator of SaMD quality systems? Are you excited about applying your quality systems experience and knowledge to an 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!
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 thousands 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.
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, New Zealand, Japan.
About the role
We are looking for an experienced and nimble SaMD quality and regulatory practitioner to oversee all aspects of our quality management system (QMS) and contribute to the execution of our regulatory strategy. You will interact with cross-functional teams to deliver on existing and new quality requirements. You will also be involved in supporting continuous improvement initiatives across the QMS.
As the Quality System Lead, you will be responsible for:
- Maintaining and continuously improving the company’s QMS, keeping it lean, compliant, and fit-for-purpose for a fast-moving software start-up.
- Support product and engineering teams throughout the product lifecycle, providing guidance on the applicable regulatory requirements and helping to shape our product and product roadmap.
- Working with external resources, compile regulatory submissions in target jurisdictions.
- Support relevant teams through training and oversight to ensure the healthy execution and maintenance of the QMS.
- Lead design control activities, including software development and maintenance, ensuring required QMS deliverables are authored, approved, and maintained to ensure continuous software delivery in Australia/NZ, USA, Japan, and other future markets.
- Represent quality and its systems during external inspections and audits.
- Ensure overall compliance and drive continuous improvement of QA processes and systems.
Must-have skills and experience:
- A minimum of 5 years working experience within the medical device industry.
- Deep understanding of QMS per ISO 13485 and FDA Quality System Requirements.
- Experience with software product development under ISO 13485, and ISO 62304.
- Experience with supporting regulatory submissions.
- Experience with risk management per ISO 14971 and IEC 62304.
- Excellent oral and written communication and the ability to effectively communicate throughout the organisation.
- Motivation to drive continuous improvement through innovation.
- Excellent interpersonal skills and a desire to engage and learn from others as well.
- Ability to work effectively in a dynamic and sometimes high-pressure start-up environment.
Great-to-have skills and experience:
- Understanding of Agile development practices as they relate to medical software development
- Understanding of AI/ML concepts within a Software as a Medical Device context
- Knowledge of anatomy and/or orthopaedics
- A passion for software technology in the medical device field