Quality Assurance Associate
Hardian Health is a digital health technology consultancy which focuses on accelerating innovative software, including artificial intelligence, to the clinical frontline by providing clinical, regulatory, health economics and IP specialist services to a global range of industrial partners, researchers, investors and healthcare providers.
We are seeking a proactive and fast-learning associate to join our Quality Assurance & Regulatory Affairs (QARA) team. The ideal candidate will have a desire to learn and grow in a QARA role, while helping build a fast-growing niche consultancy in the health technology sector. The role requires a passion for quality assurance, cutting-edge medical software and attention to detail.
We are looking for someone who wants to create a fulfilling career in QARA for software medical devices. The position comes with a defined career track, with potential only limited by your willingness to learn and engage. You will be involved with, and mentored on, regulatory submissions for cutting-edge AI and Software as a Medical Device products in all global jurisdictions, and supported by our exceptional multi-disciplinary regulatory and clinical teams.
The position offers extensive exposure and on-the-job training for implementing and running quality management systems for our clients, emphasising the use of digital tools. You will gain experience of implementing and creating systems which allow our clients to create safe, effective and cybersecure medical devices. Whilst not an engineering role, an engineering mindset is required for designing and validating tools for our clients.
The role requires critical thinking and proactive decision making, comfort in a regulatory environment. Part training role, part consulting, this exciting role is one for you to shape and adapt as both you and the company grow.
Overview of company and job details
Fully remote working (UK location of your choice), we are a virtual company with quarterly in person meet ups.
FTE Salary: up-to ÂŁ40,000 PA
Company benefits private health insurance and pension scheme
Company laptop and remote office set-up
Flexible work hours (40 per week), work when you want, fit work around your life.
28 day annual holiday allowance, guaranteed Christmas break
Details of the role
Reports to the Director of QARA.
Assist regulatory consultants in quality assurance projects, including:
Deployment and validation of Quality Management Systems
Creation of documentation for clients
Assisting in client meetings
Opportunity for exposure as to how software medical devices get made
Opportunities to gain further qualifications and experience
Skills and experience
Essential:
Bachelor's degree, ideally in a STEM subject.
Comfortable in Google Workspace and Microsoft SharePoint, Word, Excel, and Jira/Confluence. An ability to pick up new tools and systems quickly is essential.
Purpose driven. Everything we do is to help improve access to cutting edge technology for patients.
Ability to communicate complex subject matter to multiple stakeholders.
Ability to diligently manage multiple projects simultaneously and prioritise workload.
Must already have the right to work in the UK. Hardian does not offer sponsorships.
Highly Desirable:
Some experience in QARA - ideally within a functioning QMS environment (e.g. ISO 9001 or 13485).
Experience in software acceptance testing, and/or software development
Project management experience
