QA Specialist

Whilst hybrid working, you will work closely with other team members your responsibilities include:

• maintenance and continual improvement of the quality management system;


• governance of Quality Events (i.e., deviations, non-conformances, etc.), CAPAs, Change Controls and Quality Metrics;


• generating and revising SOPs and associated documents as required;


• supporting regulatory compliance to QSR, ISO, CE and other global regulatory requirements through customer complaints, audits, employee training and other QMS activities;


• generating and maintaining Design History Files and Technical Documentation for various global markets to support local regulatory and commercial activities;


• participating in risk management related activities such as verification of risk mitigation implementation in products and processes; and


• performing other duties as assigned.
  
  The QA Specialist is a newly created role that is key in helping the team succeed and enabling the company to grow and develop. You will be joining a highly motivated team that is passionate about what they do in a company that is going from strength to strength. This is an opportunity to make a difference to people's lives and play a visible role in its success., BSc in Science or similar field;


• previous experience in working in a highly regulated environment such as biotechnology or medical devices;


• experience in Quality Management Systems (ISO13485) and FDA 21 CFR Part 820;


• experience in EU MDR;


• experience with EN62304;


• internal audit and external audit experience (preferably to ISO 13485);


• knowledge of good document control practices, quality assurance terminology, methods, and common tools;


• experience in using an eQMS;


• experience working cross functionally with other departments;


• awareness of information governance best practice;


• experience in a commercial setting; and


• strong attention to detail and able to juggle multiple deadlines and manage competing priorities.


You are a highly versatile, energetic individual who is detail and task orientated. You have an entrepreneurial spirit and are practical with a positive can-do mentality. Whilst a strong team player you are also able to work independently and on your own initiative and are:


• highly competent in the use of MS Office applications;


• able to work in a fast-paced environment; and


• highly motivated
  
  TympaHealth are a team of doctors and technology experts united by a vision to help the world to hear. Currently, there are half a billion people in the world with disabling hearing loss. In the UK by 2030 hearing loss will overtake diabetes and cataracts in the top 10 global disease burdens.


Our mission is to help the world to hear and make intervention more accessible and simplified both on a local and global scale. TympaHealth is growing fast and is currently helping thousands of patients a year access vital ear and hearing healthcare services in the UK, with plans to expand globally.

TympaHealth have created a collaborative and supportive environment, everyone is valued and encouraged to contribute their own ideas and opinions.

A competitive salary and benefits package include:

25 days holiday per year (increasing to 26 after two years) + Bank Holidays

Birthday Holiday and Christmas Holiday (three additional days)

5% Company & Employee Pension Scheme Contributions

Life Assurance Scheme (four times salary)

Hybrid Working (one day a week in our London office)

Remote GP and Medical Second Opinion Services

Mental Health Support

Physiotherapy (eight sessions per year)

Life, Money and Wellbeing Support

360 Wellbeing Score, Insights and Calendar

Financial and Legal Support

1-2-1 Lifestyle Coaching

Savings and Discounts

Perkbox

There has never been a more exciting time to join our team with our growth, focus on excellence and opportunities for development in an inclusive, inspiring company.