TympaHealth are recruiting a Quality Coordinator for maternity cover on a 12-month fixed term contract. 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 the Company's success.

Key Responsibilities:

• Assisting the Quality and Regulatory Affairs Manager with the maintenance and continual improvement of the core product quality management system.
• Support Quality Systems governance of Quality Events (i.e., deviations, non-conformances, etc.), CAPAs, Change Controls and Quality Metrics.
• Generate and revise SOPs and associated documents as needed, including sending documents for approval to relevant stakeholders.
• Assist in participation of internal and external audits, checking conformity of working practice to quality system procedures and the requirements of ISO13485:2016, 21 CFR Part 820 and EU MDR.
• Assisting the Quality and Regulatory Affairs Manager with creation and maintenance of technical files for submission to regulatory authorities E.g. UKCA/CE and FDA submissions.
• Archiving (or oversee the archiving) of documentation on behalf of the Quality Department.
• Assist in delivery of training on QMS policies, procedures and good practice to employees within the organisation, including ensuring training records are kept up to date.
• Maintenance of the electronic QMS.
• Follow good information governance practice throughout this job role and ensure compliance.

Your Profile

You are a highly versatile, energetic individual who is detail and task orientated. You should be practical and adaptable with a positive can-do mentality.

 

• Degree in similar field.
• Previous experience in working in a highly regulated environment such as biotechnology, pharmaceuticals, or medical devices.
• Experience in Quality Management Systems, ideally ISO13485. Experience with EN62304 is a bonus.
• Highly competent in the use of MS Office applications.
• Knowledge of good document control practices, quality assurance terminology, methods and common tools.
• Use of an eQMS software.
• Ability to work in a fast paced start-up environment.
• Good communication skills and ability to work well with others.
• Highly motivated with a positive attitude.
• Strong attention to detail and able to juggle multiple deadlines and manage competing priorities.
• 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 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.

 

Salary & Benefits

A competitive salary and benefits package include:

·  25 Days Holiday (increasing to 26 after 2 years) + Bank Holidays

·  Birthday Holiday and Christmas Holiday (3 additional days)

·  5% Company & Employee Pension Scheme Contributions

·  Life Assurance Scheme (four times salary)

·  Remote GP and Medical Second Opinion Services

·  Mental Health Support

·  Physiotherapy

·  Life, Money and Wellbeing Support

·  360 Wellbeing Score, Insights and Calendar

·  Financial and Legal Support

·  1-2-1 Lifestyle Coaching

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.

Please click here to apply:

https://tympahealth.bamboohr.com/careers/40?source=aWQ9MTk%3D