The Role: Quality Assurance Specialist (Med Devices and IVDs)

Hours: Full Time, Permanent
Salary: £30,000 - £35,000 per annum (depending on experience)
Location: Hybrid* (Head office Nottingham)

Must have experience working in Medical Device & IVD industry

Medichecks launched the UK's first direct-to-consumer blood testing company in the UK and created a market where there was none. As well as the continued growth of our B2C business we now see considerable opportunity to grow in the B2B and B2B2C space through our technology platform, Plasma.

Our vision is to be part of everyone’s journey to better health. At Medichecks we’re building a healthcare platform for the future. We’re a team of medics, designers, engineers, and communicators who are intent on bringing our vision to life. We’d like to hear from people who want to use their skills and knowledge to improve peoples’ lives and help us create real change in the way that blood testing and insights can be delivered.

We are proud to be an employer of choice: listed by Best Company in the top 100 SME companies to work for in the UK, top 50 in the East Midlands, and top 10 Health and Social Care.

Purpose of this role

This is a new position within a growing team contributing to the quality culture of Medichecks. This role will offer development opportunities as you grow into the role and would be perfect for a candidate who already has quality experience and wants to develop their career within the industry even further.

The primary function of this role is to support the Quality and Regulatory team on a day-to-day basis to ensure coordination and compliance of quality activities across all areas of the business, ensuring policies and procedures are fully documented to support compliance and regulatory requirements.

A key element of this role will be focused on the co-ordination of Quality Assurance activities across all areas of the business whilst supporting the management of Medichecks Quality Management System. You will champion continuous improvement of Medichecks processes and contribute to the management and implementation of quality initiatives.

Role and responsibilities

• Support the maintenance, continual improvement, and audit readiness of the ISO 13485 accredited Quality Management System (QMS).
• Ensure compliance with national and international standards and legislation, including ISO 13485 and ISO 27001.
• Manage Corrective and Preventive Actions (CAPA) and non-conformances from logging through to resolution, including root cause analysis and effectiveness checks.
• Prepare and present monthly trend reports on CAPAs and non-conformities to senior stakeholders.
• Actively monitor and remain up to date with changes to industry standards, regulations, and guidance.
• Review, update, and maintain Standard Operating Procedures (SOPs) to ensure QA processes are current, accurate, and clearly communicated to relevant teams.
• Act as a Subject Matter Expert (SME) for the QMS, advising stakeholders on best practices and creating and delivering educational materials to support the wider business and promote a strong quality culture.
• Administer and manage change controls within the Q&R team from initiation to sign-off.
• Support the preparation and execution of internal and external audits, contributing as an SME where required.
• Act as a member of the internal audit team completing annual QMS internal audits.
• Complete supplier qualification and periodic supplier reviews, and maintain supplier documentation within the QMS, ensuring ongoing compliance and accuracy of records.
• Maintain back-ups of QMS and supplier documentation in SharePoint in alignment with Medichecks eQMS (MasterControl).
• Assist the Senior QARA manager in the monitoring and mitigation of QMS related business risks.
• Carry out administrative activities within the eQMS to support audit preparation, reporting, and close-out of findings.
• Develop and maintain Quality & Regulatory (QARA) department FAQs, ensuring they remain accurate and accessible.
• Communicate with key stakeholders to ensure departmental adherence to relevant SOPs.
• Identify opportunities to improve or streamline QMS processes and escalate proposals to the Senior Quality & Regulatory Manager.