Quality Assurance Manager

ZipRecruiter; Thatcham; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative organization is seeking a Quality Manager to oversee compliance with Human Tissue Authority regulations in a cutting-edge surgical skills center. This role involves managing lab operations, ensuring adherence to HTA standards, and leading documentation efforts. The ideal candidate will have a strong background in Quality Management and experience in a regulated medical device environment. Join a forward-thinking team dedicated to providing exceptional surgical education and professional development, setting benchmarks for excellence in the industry.

Qualifications

• Experience in a regulated medical device environment with HTA.
• Background in Quality Management and audit management.

Responsibilities

• Responsible for compliance with Human Tissue Authority regulations.
• Lead documentation and policy development for lab operations.

Skills

Planning and organization

IT management

Leadership

Analytical skills

Negotiation skills

Problem-solving

Project management

Experience with orthopaedic/spine surgery

Education

Diploma in medical or biological sciences

Relevant practical experience

Job description

Job Description

Job Title: Quality Manager / Designated Individual (DI)

Responsibilities

1. To be responsible as the Designated Individual under the Human Tissue Act (HTA) for the use of tissues within the scope of the Ortho Surgical Skills Centre (OSSC) Human Tissue Authority licence.
2. To play a key role in ongoing compliance with a Human Tissue License via the HTA.
3. Provide expertise in the planning, setup, and commercialization of the OSSC lab, ensuring all legislation is met to the highest standards, including lab management and Quality Management System oversight.
4. Responsible for writing SOPs, risk assessments, audits, and compliance documentation for all Anatomy Laboratory activities, maintaining HTA standards.
5. Ensure suitable practices are used in licensed activities, staff are trained, conditions of the license and third-party agreements are complied with, and all licensable activity information is properly documented and securely stored.
6. Ensure the safe retrieval, storage, distribution, and use of human tissue in accordance with HTA regulations and prepare for HTA inspections.
7. Advise stakeholders on HTA regulations related to new initiatives at the OCG lab.
8. Lead documentation and policy development related to working with human tissue.
9. Provide technical management for daily operations of the OCG lab and oversee technical staff responsible for safe lab management.
10. Assume responsibility as radiation protection supervisor, completing necessary training.
11. Undertake training in accordance with HTA regulations as required.

Qualifications - Essential

• Experience in a regulated medical device or similar environment working with the Human Tissue Authority.
• Background in Quality Management, including system maintenance, improvement, and audit management.
• Diploma, certificate, or formal qualification in medical or biological sciences, or equivalent qualifications and practical experience deemed suitable by the Authority.
• At least two years of relevant practical experience.

Qualifications - Desirable

• Membership of The Institute for Anatomical Science (IAS).

Skills and Competencies

• Strong planning, organization, and resource management skills.
• Excellent IT skills, including management and financial systems.
• Proven leadership and management skills in a laboratory setting.
• Analytical, negotiation, and problem-solving skills.
• Commitment to excellent stakeholder service.
• Project management experience.
• Experience with orthopaedic/spine surgery.

Knowledge and Experience

• Extensive practical experience and understanding of HTA regulations and compliance implications.
• Awareness of legislation on tissues and cells for human application.
• Advanced analytical and problem-solving skills.
• Ability to communicate clearly to non-specialist and senior audiences.
• Relevant practical experience for HTA licensable activities.

This job description is not exhaustive but outlines the main requirements.

Our Mission

The Ortho Surgical Skills Centre (OSSC) aims to provide a surgical education and professional development environment, delivering a tailored, best-in-class customer experience.

Our Vision

To become the leading centre for healthcare professionals and medical device companies to collaborate in surgical and educational settings, setting benchmarks for hands-on learning and education.