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Director of Design Assurance

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 4th October
Location: Runcorn
Salary/Rate: £80000 - £100000
Type: Permanent

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Our client a rapidly expanding global medical device company are looking for a Director of Design Assurance. They manufacture a variety of diagnostic devices and medical equipment servicing the cancer space. The chosen individual will have working knowledge of medical devices research & development (R&D), quality engineering systems and regulations to lead design Assurance, V&V activities during product development.The Director of Design Assurance will collaborates with R&D, QARA and Commercial teams to ensure product development, engineering processes and standards assure product quality.Role:Design, agree and roll- out goals and objectives for the team which are aligned with business strategy.Accountable for, lead and share expertise in design controls, engineering systems, risk management, regulatory and technical complianceDevelop and obtain buy- in to agreed direction in the Design Assurance, V&V, Risk Management and Compliance departmentsLead and continuously improve owned programs, strategies and methodologiesDevelop and ensure deployment of R&D tools, processes, standards, and metrics, including the establishment of best practices for product development and launchesDevelop, maintain, monitor and ensure good application of design and development quality systems to ensure compliance to applicable global regulations and improve business performanceLead team to ensure close collaboration with Project Management Office ensuring efficient delivery of activities through new and existing product developmentProvide guidance to relevant Stakeholders to achieve sustainable compliance of activities across the product lifecycle to applicable law and regulationsEnsure leadership and functional networking.Promote a culture of quality awareness and compliance, teamwork and collaboration with all involved in the generation, review and approval of design control documentation and records.Manage the effectiveness and quality of V&V and risk processes for software, hardware, systems and products.Develop and improve current system engineering processes (usability, reliability, systems engineering) and ensure best engineering practices are appliedQualifications: R&D and Engineering with people leadership in a Medical Devices/IVD industryHands-on with verification, validation, testing and qualificationsEducated in engineering ideally or equivalent work experienceLeadership and Management skillsIdeally Six Sigma Black Belt or experience of statistical tools applicationFDA QSR Part 820, ISO13485, ISO14971, IEC62366, IEC62304 etc.Quality by Design principles and systems (i.e. product requirements analysis, reliability, usability etc. 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