Quality Systems Engineer

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Key ResponsibilitiesA leader and expert in the areas of quality systems, applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, & 21CFR11.Constantly promotes awareness of best industry practices making appropriate decisions on a daily basis, Championing continuous improvement from a quality system perspective and educates functional areas on quality system requirements.Implementation of internal requirements and external laws, regulations, guidance's and standards, as applicable to the company's quality systems. Under the direction of the Senior Quality Manager, will lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.Participate cross functionally and across the business to standardise and continually improve the Quality System policies and procedures.Support Regulatory Inspections and Notified Body audits.Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organisation.Conducting internal audits to schedule and maintaining/supporting the supplier quality management process.Supporting and providing input into equipment/process validations and test method validations.Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives. Skills, Qualifications & ExperienceIdeally will possess Degree/Post-Grad in Quality Management5+ year's experience in a medical device manufacturing environment with direct experience in a Quality Systems role and with exposure to FDA / ISO13485 / CE Registration Process.Experience with involvement in Regulatory submissions would be an advantage & design/process validations and FMEAs.Lead Auditor or Internal Auditor certification an advantage.*Applicants are required to hold Full EU Working Rights/Stamp 4 Visa as sponsorship is not provided for this role.* 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