Head Of Quality

Job title : Head Of Quality
Location : London
Job type : Permanent
Salary : Competitive
Contact name : Gabriella Boxall
Contact number : +44 (0) 207 255 6655
Contact email : gabriella.boxall@seclifesciences.com
An innovative Medical Device company with exciting portfolio of products is seeking a Head of Quality. This is the perfect time to join one of the most sensational organisations, as they push the boundaries of in-vitro diagnostics (IVDs) research even further. In turn, they are improving the lives of thousands of patients across the globe. As a company, they firmly believe in the positive outcomes of a consumer-led health care system. Being the Head of Quality, you will have a fundamental impact on how infectious diseases are managed at point of care and beyond.

You Key Responsibilities:
* To promote strong and inspirational leadership to a team of 10 direct reports
* Have ownership of compliance and policy matters
* Report on Key Performance Indicators (KPIs) ensuring adherence to processes, and drive improvements where necessary
* Maintenance and continuous improvement of the QMS, to ensure compliance to EN/MDD/MDR, IVDR, FDA requirements and ISO 13485
* Reporting directly to the CEO and communicate with other key function heads as appropriate
* Have the oversight of development and maintenance of the risk management, in accordance with ISO 14971
* Implement and maintain the Company Quality Manual, ensuring it fits regulatory requirements as well company policies
* Management of Change Control and Document Control Systems, including troubleshooting problems and implementing corrective actions

You will have:
* Experience within quality assurance at managerial level to a substantial team within the Medical Device industry, including IVDs.
* Previously handled FDA and MHRA inspections,
* Strong knowledge of the current Quality Standards and Regulations impacting the IVD
* In-depth experience in maintaining and improving QMS
* Life science Master's degree (or equivalent qualification)
* Proven experience in maintaining positive interactions with notified bodies and auditing organisations
* Excellent people skills, as well as verbal and written communication skills

Your Benefits:
* Competitive salary, with a generous profit related bonus
* 25 days annual leave holiday, plus bank holidays and the day of Holiday for your Birthday
* Flexible working hours
* Private medical insurance and life insurance

To be part of such an ambitious growing company, apply directly now or reach out to gabriella.boxall@seclifesciences.com to chat about similar roles.