Job Title: Quality Manager / Designated Individual (DI)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.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 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 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.
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, orBe otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience, andProven high level of planning and organisation skills and resource managementExcellent IT skills and proven ability to use management and financial systemsProven skills in the effective management of people in a laboratory environmentProject management experienceThe 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 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….