The QA Specialist is a key position in helping the team succeed and enable 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.

Key Responsibilities:

• Responsible for maintenance and continuous improvement of the quality management system.
• Governance of Quality Events (i.e., deviations, non-conformances, etc.), CAPAs, Change Controls and Quality Metrics.
• Generate and revise SOPs and associated documents as required.
• Support regulatory compliance to QSR, ISO, CE and other global regulatory requirements through customer complaints, audits, employee training and other QMS activities.
• Generate and maintain Design History Files and Technical Documentation for various global markets to support local regulatory and commercial activities.
• Participate in risk management related activities such as verification of risk mitigation implementation in products and processes.

Your Profile

Requirements:

• BSc in Science or similar field.
• Proven Quality Assurance experience within Medical Devices.
• Experience in Quality Management Systems (ISO13485) and FDA 21 CFR Part 820.
• Experience in EU MDR.
• Experience with EN62304 is desirable.
• Certified Internal or Lead ISO 13485 Auditor.
• Highly competent in the use of MS Office applications.
• Knowledge of good document control practices, quality assurance terminology, methods, and common tools.
• Experience in using an eQMS.
• Ability to work in a fast-paced environment.
• Experience working cross functionally with other departments while also working on own initiative.
• Awareness of information governance best practice.
• Highly motivated with a positive attitude.

You are a highly versatile, energetic individual who is detail and task orientated. You should have an entrepreneurial spirit, be practical with a positive can-do mentality. You will have experience in a commercial setting as well as:

• 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.
• 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)

Hybrid Working (minimum of one day a week in the 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.