Quality Systems Specialist

This job has now expired please search on the home page to find live IT Jobs.

KEY PURPOSE OF THE ROLE: * To support and maintain contracted clients' Quality Management Systems to: ISO 13485, MDSAP, EU MDR, UK MDR, US FDA either via Activ*or their paper-based quality system* To create and implement Quality Management Systems to: ISO 13485, MDSAP, EU MDR, UK MDR, US FDA* Provide advice to those clients on QMS related queries* Provide support during clients' external Regulatory/Quality Audits* Assist the QMS, Compliance and Training Delivery Manager in maintaining Advena Ltd UK's own quality management system to ISO 13485 RESPONSIBILITIES OF THE ROLE: * To provide accurate quality management advice, in accordance with ISO 13485, MDSAP, EU MDR, UK MDR, US FDA, to all Advena UK's client base, and prospective clients* Ensure all contracted Activ* clients' systems are kept in compliance with the standard complied to, and are updated in line with notifications received by their Activ* system* Ensure all contracted clients, with paper-based quality management systems, are kept in compliance with the standard complied to, and remain up to date* To build and implement new systems for new/existing Advena Ltd UK clients, via Activ* software or paper-based* To attend clients' premises to conduct regulatory/ quality meetings, and/or clients' own external quality/regulatory audits* To conduct internal audits on clients' QMS, when requested* Support the Compliance Manager administer the Company's Quality Management System to ensure continued compliance with ISO 13485* To represent the Company in a professional and courteous manner* Any other tasks as required by the Managing Director. QUALIFICATIONS & EXPERIENCE: * Degree or equivalent certification in science related, medical, or engineering discipline is desirable, but not essential* To be experienced and knowledgeable of the medical device industry and have had at least 4 years previous experience in a Quality Management role within the Medical Device sector.* ISO 13485 Internal Auditing experience is essential* Experience in dealing with Regulatory bodies: EU Notified Bodies, EU Competent Authorities, UK Approved Bodies in an auditing capacity* Suitable general IT skills. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales