Medical Devices Quality Assurance

£50k to £70k DOE | Full time | Hammersmith, London (Hybrid or Remote)

Introduction to Doccla

We’re Doccla, the virtual ward company. We provide patients and clinicians with the transformative power of remote patient monitoring. 

Our customers are Hospital Trusts and Community Services that we partner with to deliver virtual wards. With Doccla, patients can have their care stepped up from community services or they can be discharged from a hospital ward to a virtual one. Patients get to receive treatment in the comfort of their own homes whilst health services become more efficient. Unsurprisingly, both the number of trusts we work with and the number of patients we support is constantly growing.

Doccla is a young company with big aims and a lot of momentum. We're solving real problems for patients and health systems. And we’re looking for dedicated people with a passion for healthcare to join us.

Role and responsibilities. 

As the Medical Device Quality Assurance Specialist you will report to the CTO and will primarily work with the Doccla tech team. You will enable and support our tech team by writing and reviewing quality systems and processes as well as providing expertise and advice to the team. You will also work to improve awareness, visibility, and communication throughout Doccla about quality initiatives.

In this role you will:

  • Work with senior management to create new QMS procedures as per ISO13485, that are specially for software medical device products. 
  • Author, review, approve, monitor, and maintain existing QMS procedures and processes.
  • Lead and support all internal and external audits. 
  • Lead QMS projects in creating and maintaining internal audit schedules and records including tracking CAPA activities as required. 
  • Lead and support the preparation and execution of Notified Body/UK Approved body audits including preparing reports. 
  • Assist in investigating quality issues including interacting with product suppliers.
  • Review and investigate customer complaints, determine product failure root causes, and evaluate risk of failures.
  • Work with colleagues to ensure that the quality system is appropriately understood and applied throughout the organisation on all levels.
  • Maintain technical files and test reports of product conformity according to MDR  Regulation (EU) 2017/745, MDD 93/42/EEC, and UK MDR 2002 considering all amendments.
  • Be responsible for making sure that you are aware of and prepared for any recent and planned changes to relevant regulations.

Requirements

All applicants must be:

  • Be an expert in quality management systems (ISO 13485/ ISO 9001) and their associated documentation for medical devices. 
  • Have knowledge of all relevant medical device regulations especially SaMD regulations including MDR Regulation (EU) 2017/745, MDD 93/42/EEC, and UK MDR 2002.
  • Have at least 5 years experience in authoring, reviewing, approving, monitoring and maintaining existing QMS procedures and processes within the Medical Devices industry. 
  • Have experience in the preparation of technical files for compliance with UK regulations, with expertise in SaMD products.
  • Have knowledge of MS Office including Excel, with an ability to learn other systems.
  • Have high attention to detail.
  • Be able to work independently as well as collaboratively, often with remote colleagues. 
  • Be able to remain calm and receptive in fast paced situations.

Please also share with us if you:

  • Have specific experience of QMS for SaMD.
  • Have software development experience.
  • Have experience of country specific QMS such as 21 CFR Part 820 for the US.

How we work

We empower everyone to take ownership and responsibility for the company and their role within it. We act ethically and think of helping patients and protecting their safety first. 

Whatever your role is, to thrive at Doccla, a can-do and action oriented attitude is essential. As is being a clear and open communicator who is receptive to feedback.

We practice hybrid working with offices in London and Stockholm and a team across Europe. 

Most of the team lives in London and works from the Hammersmith office one to three days per week. For your role we hope you will join us at least once or twice a week. To tempt you in, we provide a team lunch most days as well as convivial company and the perks of working from a WeWork. However, for this position we are accepting applications for more remote working with office visits more infrequently.

We value our people. So we always look to progress existing members of the team rather than hire from outside. 

We have a generous employee equity pool that you can be part of. This means that as the company continues to grow you’ll have a share in its success. 

Finally, we also have a very generous benefits package. This includes a monthly budget of £70 to spend on Heka, our employee wellness platform. On Heka you can spend this budget on everything from Gusto boxes to massages, climbing lessons to yoga, gym memberships and more.

If this role appeals and you would like to join the team please send your CV and a cover letter outlining your interest in Doccla and in this role to hiring@doccla.com.

Tell us more about you

We would love to have you in our team!
Thank you! We’ll be in touch.
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