Quality Management Specialist
4 weeks ago
HealthHero Group is a pioneering digital-first healthcare provider, connecting innovative digital tools with gold-standard clinical expertise to revolutionize patient care and optimize healthcare efficiency. With operations in the UK, Ireland, France, and Germany, our mission is to simplify healthcare and enhance lives.
We are seeking an experienced Quality and Compliance Manager to join our Clinical Product Team. This exciting role will involve:
- Providing expert guidance on product quality, compliance, and governance across the organization.
- Serving as a trusted business partner for relevant departments and areas, focusing on medical device regulations.
- Ensuring the quality and compliance of the entire product lifecycle, including maintaining relevant standards and certifications.
You will be a key reference point within the organization, championing our quality and improvement culture, and serving as a subject matter expert in your specialized area.
This role requires exceptional discretion, initiative, pragmatism, independent judgment, and decision-making skills, with a commitment to delivering high-quality services at all times.
The position offers flexible hybrid working arrangements from home and at our Bracknell office, with occasional travel to other HealthHero sites or external partners as required.
Key responsibilities include:
- Chairing relevant meetings and committees as part of the Quality Management System.
- Leading the transition of Class 1 Medical Devices to Class 2a under the EU MDR framework, collaborating with the Notified Body.
- Preparing for ISO13485 audits and ensuring the maintenance of our certified quality management system throughout the year.
- Ensuring compliance with clinical risk management standards throughout manufacturing, implementation, and documentation.
- Providing information on reported quality and safety issues, enabling informed escalation and reporting to relevant stakeholders, including the MHRA.
- Auditing key systems, documenting processes, training, and support materials.
- Compiling and maintaining QA documentation to support business development, reviewing bid responses, and providing information for procurement frameworks and diligence activities.
- Managing Clinical Product Safety Documentation and Technical Files, adhering to regulatory standards and timescales.
- Developing and implementing processes to monitor and report actions resulting from audit reviews.
- Supporting staff across the organization in implementing and reviewing localized requirements for compliance, governance, and regulations globally.
The estimated salary for this role is £65,000 - £80,000 per annum, depending on experience.
To succeed in this position, you should possess:
- Knowledge and experience in quality management and medical device governance within an ISO 13485 accredited healthcare organization.
- Desirable – experience with software as a medical device, including MDR submissions.
As a valued member of our team, you can expect:
- A company pension scheme.
- Access to HealthHero healthcare services, including a private 24/7 GP service and Employee Assistance Programme.
- 25 days holiday + 8 days bank holiday and an extra day off for your birthday.
- Electric car scheme.
- Cycle to work scheme.
We look forward to receiving your application
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