£30k - 45k per year
8 months ago
Quality Specialist - Medical Devices
UK - WEST LONDON
REGULATORY & QUALITY – REGULATORY & QUALITY
PERMANENT, FULL TIME
We are a team on a mission, to put accessible and affordable healthcare in the hands of every person on earth. Our mission is bold and ambitious, and it’s one that’s shared by our team who shares our values, to dream big, build fast and be brilliant.
To achieve this, we’ve brought together one of the largest teams of scientists, clinicians, mathematicians and engineers to focus on combining the ever-growing computing power of machines, with the best medical expertise of humans, to create a comprehensive, immediate and personalized health service and make it universally available.
We have won many awards for our innovation and ingenuity.
Our people aren’t just part of a team, they’re part of something bigger. We’re a vibrant community of creative thinkers and doers, forging the way for a new generation of healthcare.
We’re only as good as our people. So, finding the best people is everything to us. We serve millions, but we choose our people one at a time…
What are we looking for...
- Responsibilities include but are not limited to:
- Reviewing regulations and international standards and translating requirements to the appropriate sections of the QMS.
- Administering and maintaining controlled documents and records, including the Document Control Master list, in accordance with documented procedures and guidelines.
- Developing and implementing the eQMS, managing the system and supporting technical teams in its use.
- Developing and delivering training on QMS processes as well as the eQMS.
- Liaising with HR and other teams on the approval of new/updated QMS documentation and training requirements.
- Contributing to Corrective Actions and Preventive Actions processing.
- Supporting internal and external Quality audits.
- Degree in a related field in Engineering, Healthcare or Law.
- At least 3 years of experience in a Healthcare company.
- Experience with Regulatory, Quality and Compliance tasks.
- Software development (SaMD) experience or understanding is highly desirable. Interest is a must.
- Experience of start-up culture and ways of working is beneficial
- Excellent eye for detail and accurate.
- Excellent verbal and written skills.
- Ability to multitask.
- Ability to prioritise workload in a fast-paced environment.
Who fits the role...
- You need to have great curiosity – be inquisitive and challenge the status quo.
- We are looking for a confident critical-thinker that can jump into many different problems, markets and situations and come up with tactical recommendations.
- You need to think logically and creatively to find different solutions.
- We need someone who can work with people from around the world, taking the time to understand their local nuances and challenges, without getting bogged down in why something might not work or may not be working.
- We need someone who is invigorated by delivering impact – and seeing the tangible effects.
- You need to want to make change now – this is less about creating an incredible strategy that will be implemented over the next 5 years, and more about processes that can change the business in the next 6 months.
- There’s a lot to do, so we need someone who can prioritise and make decisions intelligently using data to direct them.
- You'll definitely do some number-crunching – it’s important to be able to quickly identify issues, inefficiencies and how big these might be.
- Competitive salary + share package
- One of the nicest offices you’ll ever see
- Free healthy breakfast, and snacks
- On site table tennis and video game competitions
- Regular social gatherings and an intimate, collaborative environment
- A real entrepreneurial spirit and drive to make a tangible difference in the world
- Free weekly yoga or football sessions
- Pension scheme
- BUPA health and life insurance