Quality Manager & Designated Individual

Cure Talent; Thatcham; On-site; GBP 40,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Quality Manager & Designated Individual to lead compliance and quality oversight in a cutting-edge anatomy lab. This role offers a unique chance to manage regulatory activities and enhance lab operations within a rapidly expanding health technology company. The ideal candidate will possess strong experience in HTA-regulated environments and a proven background in Quality Management, ensuring adherence to high standards of safety and quality. Join a team dedicated to advancing surgical education and making a meaningful impact in the medical field.

Qualifications

• Strong experience in HTA-regulated environments with understanding of regulations.
• Proven Quality Management background in medical devices or healthcare.

Responsibilities

• Ensure compliance with Human Tissue Authority regulations and governance.
• Maintain Quality Management System and oversee audits and training.

Skills

HTA Compliance

Quality Management

Stakeholder Engagement

Analytical Problem-Solving

Education

Qualification in Biological or Medical Sciences

Job description

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Base pay range

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Connecting the best talent in QARA with Innovative MedTech & STEM Organisations

Cure Talent is supporting an advanced surgical skills centre delivering world-class education and development to the orthopaedics sector.

They are seeking a Quality Manager & Designated Individual to oversee their Human Tissue Authority license.

This role offers a rare opportunity to manage compliance, lab quality systems, and regulatory oversight for a cutting-edge anatomy lab used for surgical training and demonstration.

You will:

• Act as the Designated Individual under the Human Tissue Authority, ensuring compliance with licensable activities, third-party agreements, and governance protocols.
• Maintain and develop the Quality Management System, including SOPs, risk assessments, audits, and compliance documentation.
• Oversee traceability, storage, and use of all human tissue, ensuring adherence to HTA requirements.
• Lead HTA inspections, internal audits, and staff training across all licensable activities.
• Advise internal stakeholders on HTA matters to support new initiatives, lab operations, and continuous improvement.
• Take responsibility as the Radiation Protection Supervisor.

You will need:

• Strong experience in HTA-regulated environments, with a clear understanding of regulations and inspection processes.
• Proven Quality Management background, ideally within medical devices, biosciences, or healthcare.
• A relevant qualification in biological or medical sciences, or equivalent practical experience.
• Excellent communication and stakeholder engagement skills.
• High attention to detail and strong analytical problem-solving abilities.

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Legal

Industries

• Medical Equipment Manufacturing, Education, and Technical and Vocational Training

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