Director of Quality - Digital Health
Digital Health is rapidly changing the landscape of patient care, and we’re very pleased to say that Zest Medical is partnered with one of the leaders in the field. They’ve created an AI driven software which has proven to have excellent outcomes in the treatment of Mental Health conditions for a wider patient base than traditionally accessible. Now - following success on a service based model - they need a Director of Quality to create and implement a strategy for the software as a product.
- A background in the Quality management of integrated software in Medical Devices, or Software as a Medical Device.
- Bachelor’s degree or higher in a Scientific, Engineering or wider Healthcare discipline.
- Experience of the relevant requirements in major regulatory bodies (FDA, MHRA, EMEA, PMDA & EU National bodies).
- Evidenced success in creating and implementing a new QMS.
- Strong understanding of requirements in setting out Quality strategies, and varying requirements when rolling them out globally.
- Background of working within a digitally focussed healthcare environment, ideally in the NHS.
- Comfortable in both a ‘hands on’ and strategic capacity. This will be the foundation position of the team, not only creating the strategy, but also putting it in place. As a result, a willingness to be directly involved in implementation is a necessity.
Your new job:
- Reporting into the CEO, be the foundation of a Quality team for an innovative AI driven Medical Device software in the Mental Health space.
- Work with an exciting SME business in Cambridge to set out a new QMS and harmonise it in the wider business.
- Review and approve the processes for effective route cause analyses and CAPA procedures to support the new QMS.
- Provide quality reviews of new product offerings.
- Create and deliver reference information to members of the business as to quality expectations and provide further training where necessary.
- Ensure and be responsible for internal compliance across Quality, Information and Data systems. Also review and approve third party compliance where necessary.
- Act as the senior point of contact for quality in relation to internal and external audits.
Your new employer:
- An SME leader in the rapidly developing Digital Health Space
- Great growth potential in the comparatively newly explored area of Mental Health
- A company with an evidenced benefit to patients and a concrete plan of growth
Our client has shown willing to be flexible for the right candidate and would like to be market-led. A consultant at Zest would be happy to give you some more information after going through your background following an application.
*Please note that Zest Medical – or any division of Zest Business Group – will never send your CV to any of our clients without your consent and after a phone conversation.*
Contact: Jason Cox
Telephone: 0114 229 1672