Do you have a deep and practical understanding of medical device quality systems? Are you excited by the QMS intricacies of software as a medical device? If this is the challenge you’ve been looking for, we would love for you to join our journey.
About the business
Formus Labs is a New Zealand-based company developing ground-breaking 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 start-up with a highly talented team from diverse personal and professional backgrounds, including Stanford, Autodesk, Xero, and Corin. This team has built an amazing product and we want you to join us on this journey.
Formus Labs has an ISO 13485 certified quality management system (QMS) for a software product. Our product, the Formus Platform, is a software as a medical device. Applications on the Formus Platform currently have regulatory approval in New Zealand and Australia, with US FDA 510(k) in progress.
About the role
Formus Labs is looking for a highly experienced quality systems engineer to support the execution of all aspects of the quality system. Reporting to the Head of Regulatory and Quality, you will also be involved in continuous improvement of internal processes to meet and maintain international regulatory requirements.
- Support software development and maintenance activities by reviewing development plans, protocols and reports
- Lead and support risk management activities throughout product lifecycle
- Execute post-market activities, including but not limited to complaint handling and problem resolution
- Support the development and engineering team to address quality issues during development and testing
- Support investigations within the QMS (CAPAs, complaints etc.)
- Support QMS improvement efforts to meet and maintain international regulatory requirements
- Support ongoing maintenance of all aspects of the QMS, including but not limited to training, document control, and supplier management
Benefits and Perks
You will enjoy...
- Being part of a high-growth venture-backed start-up with international users and customers
- Competitive remuneration package with the possibility of incentives and share options.
- Generous private NZ health insurance
- Flexible working environment with a highly functional remote-work culture.
- Collaborating with a team of talented individuals to make a real difference to patients’ lives.
Skills and Experience
You will have...
- A quality background backed by a minimum of 5-7 years working experience within the medical device industry, ideally within the software as a medical device sector.
- Deep understanding of Quality Management Systems and the requirements of ISO 13485 and FDA Quality System Requirements
- Extensive experience working across various aspects of the QMS, including but not limited to supplier management, auditing, training, and post-market activities.
- Experience with software product development under ISO 13485, ISO 14791, ISO 62304, and ISO 82304.
- Solid understanding of risk management of software medical devices under ISO 14971
- Ideally, knowledge of anatomy and/or orthopaedics.
- Strong organization skills and attention to detail
- Motivation to drive continuous improvement through innovation.
- 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.
- Work effectively across engineering, customer success, product, and regulatory team members in a small Agile environment.
- A passion for software technology in the medical field