Axial3D is a leading provider of advanced medical imaging software solutions. Our cutting-edge technology is transforming the healthcare industry by enabling healthcare professionals to visualize and analyze medical imaging data in a more efficient and effective manner.
Headquartered in Belfast, Northern Ireland Axial3D provides solutions to over 300 hospitals, medical device manufacturers, and other healthcare companies around the world. Specializing in the delivery of 3D printed anatomical models and 3D visualizations and services to the healthcare sector, Axial3D provides machine learning-based solutions that support the integration of 3D patient-specific solutions into surgical care pathways and scaling patient-specific programs.
Ideal location for the position would be in Belfast.
The Role
As a senior QARA you will be responsible for improving and assisting implementation of the Axial3D Quality Policy and Procedures to facilitate company certification and compliance with ISO certifications. As Senior QA/RA Associate, you will work closely with the Quality Assurance and Regulatory Affairs team to improve processes and compliance of the Information Security and Quality Management System (IS & QMS).
You will promote awareness of the quality and customer requirements throughout the company, particularly with the Operations and Software Development teams responsible for producing patient-specific 3D anatomical models and files.
You will assist with the following:
- Ensure documentation of the processes needed for the support of quality management are in place
- Report on the performance of the QMS
- Report and manage NCR, CAPA and Change Controls identified within the company
- Assist with internal, external and supplier audits as required
- Reviewing and providing input to Post Market Surveillance and Vigilance processes
- Developing awareness and adoption of applicable standards throughout the organization
You will also be responsible for:
- Assisting and reviewing Medical Device Files, Technical Documentation and Device Master Records as required
- Maintain an up-to-date awareness of relevant legislation which may impact the QMS
- Facilitate productivity, process improvements and effectiveness across the organization
- Provide training sessions to ensure the understanding and compliance of all staff
- Promote the benefits of the quality system to all staff
- Facilitate and support the software engineering team with production of compliant Software as a Medical Device (SaMD) including
- Facilitate and support the Operations Team to ensure processes are in place for the controlled production of custom made patient specific 3D anatomical models and files
- Perform final QA release checks on products in preparation for dispatch
For this opportunity you should have:
- Experience of working with ISO 13485 including lead auditor certification is essential
- Minimum of 5 years experience working in a similar role in the medical device industry
- Experience in generation of technical documentation
- Awareness of medical device regulatory requirements including Medical Device Regulation (MDR) and FDA
Education Requirements:
- Bachelor's degree (or above) in a scientific or technical discipline
- Lead Auditor Qualified
Other Requirements:
- Strong communication and organizational skills
- Knowledge of ISO 14971, IEC 62304 and IEC 62366
- Awareness of Data and Information Security principles
- Awareness of global regulatory submissions and market access requirements
Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees. It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.
