Quality Manager (QMS & Compliance)
Are you an experienced quality professional with expertise in ISO 13485 and risk management, looking to take ownership of QMS and compliance within a growing medtech company? This is a unique opportunity to lead quality strategy for an innovative IVF technology start-up.
THE COMPANY
This pioneering medtech company is developing microfluidic devices designed to transform IVF treatments worldwide. By combining cutting-edge microfluidics with biocompatible materials and robust regulatory frameworks, they aim to deliver safer, more consistent embryo culture platforms that improve patient outcomes. Backed by Innovate UK and led by a multidisciplinary team of scientists, clinicians, and engineers, the company is on an exciting growth trajectory.
THE ROLE
As Quality Manager, you will take full ownership of the company's Quality Management System (QMS), leading ISO 13485 certification, supplier qualification, and risk management activities. You will oversee validation processes, ensure compliance with biocompatibility standards, and maintain inspection readiness with notified bodies and regulatory agencies. This is a hands-on role, where you will shape the quality culture, build robust systems, and ensure that products meet the highest safety and compliance standards as they progress toward clinical adoption.
ABOUT YOU
You'll be successful in this role if you bring:
* At least 5 years of experience in quality management within the medical device sector (Class II devices or consumables preferred).
* Proven expertise in ISO 13485 implementation and certification.
* Hands-on experience with QMS software (e.g., Greenlight Guru, MasterControl, SimplerQMS).
* Strong project management, documentation, and auditing skills.
LOGISTICS
* Location: Leeds, UK. 3 days onsite required per week at a minimum.
* Salary: £50,000 – £60,000.
* Contract: Full-time, 2 years (aligned with Innovate UK funding; extension possible).
If this sounds like the right move for you, apply now.
I look forward to hearing from you