Quality Assurance Training Lead, UK

Quality Assurance and Regulatory Affairs      ·       London, UK       ·       Full time

Giving the world more time. 

For the first time in human history we have the technology, data, and insights to redefine health. Together with our partners, we will make the leap from reactive to proactive medicine. By collectively benefiting from the data we individually generate, we can all live our longest, fullest lives.  Huma partners with scientists, technologists, healthcare, and life sciences professionals to understand, treat, and ultimately prevent ill health. Giving knowledge and power to those with medical conditions, while saving clinicians time, energy, and valuable resources. 

We are looking for a Quality Assurance Training Lead who will be the subject matter expert for training within our Medical Device Quality Management System.

By joining the Quality Assurance and Regulatory Affairs (QARA) team, you will contribute to solving their key challenges in the  development of Software as a Medical Device. Using problem solving skills and utilisation of different strategies to support resolution of design, manufacturing and regulatory challenges in a fast paced digital environment.

Your mission

• Make sure that the organisation training process complies with the applicable regulations and standards (e.g ISO 13485, MDR 2017/745, 21 CFR Part 820)
• Ensure that the training process is audit ready at all times
• Lead improving the image of the training processPrepare and conduct training sessions (including training materials) 
• Identify and implement continuous improvement through the training process
• Work with different teams across the whole organisation on CAPAs, NCs 
• Report on regularly basis KPIs related to the training process 
• Maintain the training matrix

From day one in this role we’ll expect you to have

• Excellent working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, ISO 14971
• Experience with Medical Devices
• Ability to manage multiple projects at once
• Evidence of team working skills and flexibility
• Attention to details

It’s great, but not required, if you have

• Academic background in healthcare, medical device or pharmaceuticals
• Experience in Good Clinical Practice 
• Experience of Software as a Medical Device (SaMD)

You will thrive at Huma if you are

• Resilient – show adaptability, be a pro-juggler and have the ability to move fast
• A Self-solver – you are resourceful and  seek solutions through collaboration
• A strong communicator – you practice open and clear dialogue, while listening with fairness 
• Detail oriented – working with people’s health means we obsess over every detail and make sure we get it right 
• A Problem-solver – a passion to creatively find solutions that solve one of the biggest global challenges – human longevity
• A collaborator – you achieve some of the greatest results by working together

What we can offer you

• Progressive private health insurance with AXA Health
• EAP scheme and gym membership discount with AXA
• AIG Life & income protection scheme
• Generous share options – every employee is an owner
• 25 days paid vacation + UK bank holidays
• Home office allowance to support home working
• Bike2Work scheme
• Season ticket loan
• Family first culture – giving the flexibility you need
• Growth & development opportunities

Come join us!  

We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We aspire to create an environment where everyone has the opportunity to do their best work. We are always looking for ways to improve so if you have any suggestions, please get in touch. 

Huma is committed to ensuring the safety of all current and prospective global employees during the ongoing COVID-19 Pandemic. We’ve developed technology-enabled recruitment and on-boarding processes, all Huma people have been provided with a home office allowance and we’ve developed a progressive communications model. We will continue to adapt as we work together in this new world of distributed working.

Dear recruitment agency friends: Huma attracts an amazing number of direct candidates and we do not need any help at this stage, so please do not send us unsolicited agency resumes. This is not a great use of your time, and we will not accept any liability or fees for any resumes or candidates which we have not asked you to find for us.

Please click here to apply.