Quality Assurance Manager

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. To play a key role in ongoing compliance with a Human Tissue License via the HTA. Provide expertise in the planning, set-up and commercialisation of the OSSC lab, meeting all required legislation to the highest standards. Including, but not limited to, ongoing lab management and management of an appropriate Quality Management System.

Responsible for the writing of SOP’s, risk assessments, audits and compliance documentation for all aspects of the Anatomy Laboratory activities and facilities maintaining HTA standards applicable to all licensable activities carried out within the facility. To ensure that suitable practices are used in undertaking the licensed activity, other persons working under the licence are suitably trained and responsible, the conditions of the licence and third-party agreements are complied with and that all information relating to licensable activities is available for tracing donations, current, correct and held securely. To ensure the safe retrieval, storage, distribution and use of all human tissue in accordance with HTA regulations. To present evidence of compliance with HTA regulations during the HTA inspections.

To advise and inform relevant stakeholders of HTA regulations relating to the implementation of new initiatives at the OCG lab. To ensure the correct regulations are documented and be the lead on policies in relation to working with human tissue. To provide technical management as appropriate in the day to day running of the OCG lab for other technical services staff employed with responsibility for the management and safe running of the lab. Take responsibility as the radiation protection supervisor, completing appropriate training. To undertake training in accordance with HTA regulations, as and when required.

Qualifications - Essential

• Previous experience working in a highly regulated medical device or similar environment and working with the Human Tissue Authority.
• Background in Quality Management with Quality Management System maintenance, improvement and audit management.
• A diploma, certificate or other evidence of formal qualification in the fields of medical or biological sciences, or be otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience.
• Have at least two years’ practical experience which is directly relevant to the activity to be authorised by the licence.

Qualifications – Desirable

• Membership of The Institute for Anatomical Science (IAS)

Skills and Competencies:

• Proven high level of planning and organisation skills and resource management.
• Excellent IT skills and proven ability to use management and financial systems.
• Proven skills in the effective management of people in a laboratory environment.
• Excellent analytical, negotiation and problem-solving capability.
• A commitment to delivering an excellent service to stakeholder/users.
• Project management experience.
• Experience with orthopaedic/spine surgery.

Knowledge and Experience

• Practical extensive experience and understanding of HTA regulations and procedures and the implications of non-compliance.
• It is expected that DIs have an awareness of all the relevant legislation covering the use of tissues and cells for human application.
• Proven advanced analytical problem-solving skills/capability.
• Ability to communicate clearly to non-specialist and senior level audiences.
• Extensive practical experience which is directly relevant to the activity to be authorised by the HTA licence.

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

Our Mission

The Ortho Surgical Skills Centre (OSSC) has one mission: to provide an environment for surgical education and professional development. Through our all-in-one offering, we are committed to delivering a best in class customer experience that is tailored to your medical education needs.

Our Vision

Our vision is to become the go-to centre for healthcare professionals and medical device companies to collaborate in a surgical and didactic setting, establishing the benchmark for hands-on learning and education.