The Wider Research Project
The Quality Controller is required to contribute to a new overall project led by Prof. Vinny Wade focused on the development of an AI Voice Technology companion to help care for the elderly. The Quality Controller is responsible for ensuring that the software meets regulatory standards and functions safely and effectively in a medical context. They will support bridging the gap between the clinical expertise and the technical development to ensure that the software meets the standards of healthcare providers and patients.

AmethystCare is the voice technology companion that helps care for people with mobility-related illnesses and dementia at home, allowing them to live independently for longer. AmethystCare will offer an AI-driven voice assistant that is delivered through Amazon Alexa devices (or similar) to B2B care and health organisations that seek to enable patients to stay at home as long as possible. The assistant will monitor patient loneliness, and cognitive decline, assist with medicine adherence, and detect falls or other emergencies. The data will be tracked through our analytics hub. This will be tracked over time to allow medical professionals and carers to have a detailed view of the patient’s progress and ability to live at home. This service both reduces the cost of care and enables organisations to provide a better service but also improves patients’ lives and gives more data to improve patient outcomes.

A suitable candidate will have a Primary Degree and 6 years of research/ industrial experience. They will be responsible for medical device certification and will work closely with the regulatory consultant and project team to ensure that AmethystCare develops a GenAi approach and quality management system that will comply with medical certification requirements.

The overall team in this project will consist of the commercial lead, two developers, clinical lead and one AI researcher. The position is fully in-person and requires the person to be based in Dublin, Ireland.

Context

The position will be based in the ADAPT SFI Research Centre, hosted in the School of Computer Science & Statistics, Trinity College Dublin. ADAPT is the world-leading SFI Research Centre for AI-Driven Digital Content Technology, and brings leading academics, researchers and industry partners together to deliver excellent science, engage the public, develop novel solutions for business across all sectors and enhance Ireland’s international reputation. The ADAPT Centre is hosted and coordinated in the School of Computer Science and Statistics, TCD.

The School of Computer Science and Statistics is ranked #1 in Ireland (QS Rankings) and is a proud recipient of a Bronze Athena Swan award, attained in 2021. As part of the School’s on-going actions in relation to equality, diversity and inclusion it welcomes all applications that meet the criteria below and particularly those from under-represented groups. The School offers a collegiate and supportive environment to all its staff and works to ensure that all its staff and students can perform at their best while putting in those steps that facilitate a healthy work/life balance
Main Responsibilities

Quality Controller

• As part of the overall project, the Quality Controller will work on the following tasks:
  Rolling out a Quality Management System (QMS)
  Preparing and maintaining documentation for regulatory submissions and audits
  Provide insights and expertise to guide the design and development of software.
  Ensure the software aligns with clinical workflows and standards.
  Ensuring the software complies with relevant regulatory standards, such as FDA regulations (21 CFR Part 820 for medical devices), ISO 13485, IEC 62304 (for software lifecycle processes), and GDPR for data protection.
  Report regularly to the PI and Commercial Lead of the project, and interact regularly with other team members to maintain momentum in the project.
• Additionally, they will support other team members with the following tasks:
  Collaborate with software developers, designers, and the clinical lead to create user-friendly and clinically relevant software.
  Ensure that the software complies with healthcare regulations and standards by working with the clinical lead in rolling out a QMS system and becoming a Class 2 medical device in the EU. Along with HIPAA compliance and FDA approvals in the United States.

Administrative

As a Quality Controller in Adapt, the person will occasionally be required to engage in administrative tasks in support of the PI and Commercial Leads overall activity. This may include drafting sections of reports for funding bodies; organising a programme of suitably themed group meetings and seminars; contributing to research funding proposals; drafting of ethics applications; and other such tasks as they arise.

Person Requirements
The Quality Controller will require a range of knowledge, skills and attributes for successful performance in the role. The successful candidate is expected to:

• Have excellent written and oral proficiency in English
  Be skilled at taking research ideas and draw innovative conclusions, or see new solutions
  Have excellent communication and interpersonal skills
  Be willing to work as part of a multidisciplinary team and learn new cross-over skills as well as transfer skills to others
  Be highly organised in their work, with an ability to balance medium term and longer-term objectives in a project.
  Ability to represent the group at appropriate events.

Qualifications

A suitable candidate will have a Primary Degree and 6 years of research/ industrial experience. They will be responsible for medical device certification and will work closely with the regulatory consultant and project team to ensure that AmethystCare develops a GenAi approach and quality management system that will comply with medical certification requirements.

Knowledge & Experience (Essential & Desirable)
Essential:

• A suitable candidate will have a Primary Degree and 6 years of research/ industrial experience.
  Experience in developing and implementing quality management systems (QMS) tailored to SaMD
  Performing internal audits to ensure adherence to quality standards and continuous improvement processes.
  Ensuring the software is user-friendly and meets performance criteria under different conditions.
  Evaluating the impact of changes on the overall system and mitigating any potential risks.
  Strong commitment to their own professional development

Desirable

• Providing training to staff on quality standards, regulatory requirements, and best practices for SaMD.
  Keeping the team updated on new regulations and industry standards.
  Contribution to successful funding applications
  Exposure to standard tools for Software as a Medicla Device (SaMD) management
• Benefits
  Competitive salary
  High-end computer and peripherals
  Dedicated desk in shared office space, with generous social spaces
  A creative and enabling environment with impactful research
  Pension and social insurance (PRSI) included
  Trinity Day Nursery
  Travel Pass Scheme
  Bike to Work Scheme
  Employee Assistance Programme
  Sports Facilities
  22 days of Annual Leave
  Paid Sick Leave
  Training & Development
  Staff Discounts locally

Application Procedure

Applicants should provide the following information when applying:

1. A motivation statement outlining their interest and suitability for the position.
2. A comprehensive curriculum vitae, including a full list of publications.
3. The names and contact details (e-mail) of three referees.

Deadline for applications is 31^st Oct 2024.

Applications should be sent to the below people. Please include the job title in the subject line:

Conor McNally, [email protected]

Rebecca McManus, [email protected]

Vincent Wade, [email protected]

Note:

Candidates who do not address the application requirements above will not be considered for interview.

Further Information

Informal enquiries about this post should be made to Conor McNally ([email protected]).