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Director of Design Assurance

Job LocationRuncorn
EducationNot Mentioned
Salary80,000 - 100,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

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 knowledgeof 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 compliance
  • Develop and obtain buy- in to agreed direction in the Design Assurance, V&V, Risk Management and Compliance departments
  • Lead and continuously improve owned programs, strategies and methodologies
  • Develop and ensure deployment of R&D tools, processes, standards, and metrics, including the establishment of best practices for product development and launches
  • Develop, maintain, monitor and ensure good application of design and development quality systems to ensure compliance to applicable global regulations and improve business performance
  • Lead team to ensure close collaboration with Project Management Office ensuring efficient delivery of activities through new and existing product development
  • Provide guidance to relevant Stakeholders to achieve sustainable compliance of activities across the product lifecycle to applicable law and regulations
  • Ensure 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 applied
Qualifications:
  • R&D and Engineering with people leadership in a Medical Devices/IVD industry
  • Hands-on with verification, validation, testing and qualifications
  • Educated in engineering ideally or equivalent work experience
  • Leadership and Management skills
  • Ideally Six Sigma Black Belt or experience of statistical tools application
  • FDA 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 andWales

Keyskills :
ValidationIVDManagerDirectordesignqualityquality assurancemedical deviceV&V

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