We have a 6-month fixed term contract for a QMS professional to work closely with other departments across the organization in preparation for external audits. 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.

Key Duties and Responsibilities:

The main focus of the role will be to support the Quality and Regulatory Affairs Manager in the management, development and implementation of an efficient and effective Quality Management System (QMS) and ensuring all activities comply with applicable standards/regulations including EN ISO 13485, EU MDR and FDA requirements

· Assist other departments across the business to identify, record, investigate and conclude nonconformances /potential nonconformances in accordance with document procedures for both software and hardware medical device components

· Act as a CAPA lead to provide support throughout all CAPA phases including risk

· evaluation, identification of root cause(s), determination of corrective / preventive actions and CAPA effectiveness and closure

· Monitor / track CAPA status, taking appropriate steps to ensure actions are conducted in a timely manner in accordance with planned arrangements

· Provide guidance and support to all departments to:

o address findings raised in internal and external audits

o ensure all software used as part of the QMS is validated and documented appropriately

o ensure SOP and quality records are maintained

· Occasionally visit Exeter to support Warehouse and Customer Support, which may require overnight stays.

· Carry out any ad hoc duties and responsibilities as assigned by the QARA Manager for specific Business needs.

· Daily QMS Management activities

Your Profile

You are a highly versatile, energetic individual who is detail and task orientated. This role is hands-on and involves assisting other departments in drafting necessary procedures and quality records.

· Degree level in Life Science / Engineering or equivalent, together with minimum 4 years relevant experience within the medical device industry

· Good working knowledge of ISO 13485:2016, EU MDR, EN 62304, FDA QSR and other applicable standards/regulations

· Strong attention to detail and able to juggle multiple deadlines and manage competing priorities.

· Have a sharp eye for detail and ensure that the company is presented correctly.

· Excellent written and verbal communications skills

· Strong team player but also be able to work independently.

The Company

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 ten 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.

Salary & Benefits

A competitive salary and benefits package include:

25 days holiday (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)

Car Allowance

Hybrid Working (One day in the office) (Based at London)

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.