Full time
Cork, Ireland, Hybrid, or Remote ±2 hours GMT
Company overview
CergenX is an innovative medical device company based in Ireland, focused on developing cutting-edge neurotech devices for newborns. Our first device leverages EEG technology combined with AI to detect potential brain injuries at birth, using a simple, 15-minute test. As we prepare for FDA approval and release in the US and EU, we are expanding our team to include a dedicated Lead Medical Quality Assurance Specialist.
Job description
The Lead Medical Device Quality Assurance Specialist will play a crucial role in ensuring that our device meets all regulatory standards and requirements. This position involves ensuring rigorous testing and validation of hardware and software components, maintaining compliance with industry standards, and contributing to the continuous improvement of our quality management systems.
Responsibilities
Develop and implement quality assurance policies and procedures.
Conduct thorough testing of both software and hardware components to identify any issues or defects.
Collaborate with the development team to ensure quality considerations are integrated throughout the product development lifecycle.
Manage the documentation process for QA procedures and ensure compliance with regulatory standards, including FDA and EU regulations.
Participate in the design and execution of validation protocols for the device.
Lead the efforts to obtain and maintain certifications for our medical device.
Provide training and support to team members on quality assurance processes and best practices.
Prepare quality documentation and reports by collecting, analysing, and summarising information and trends.
Stay up-to-date with industry standards, regulatory requirements, and new testing methodologies.
Experience & qualifications
Bachelor’s degree in Engineering, Quality Assurance, or related field.
Minimum of 3-5 years of experience in quality assurance, preferably in the medical device industry.
Familiarity with regulatory standards and certification processes relevant to medical devices, such as FDA and EU regulations.
Experience with software QA tools and processes.
Strong understanding of hardware and software development lifecycles.
Strong test automation experience
Desired Skills
Knowledge of Jira and XRay beneficial
Behaviour Driven Development (BDD)
Experience with QMS systems such as Qualio
Excellent analytical and problem-solving abilities
Detail-oriented with a commitment to accuracy and quality
Strong communication skills, both verbal and written
Must be Highly Collaborative with the ability to work independently and as part of a team
Knowledge of AI applications in healthcare is desirable
How to Apply
If you're interested in this position, please send your CV to jobs@cergenx.com.