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Director of Design Assurance

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 15th October
Location: Runcorn
Salary/Rate: £70,000 - £100,000
Type: Permanent
Start Date: ASAP

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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 device 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 electromechanical, software, hardware, systems and products.
  • Develop and improve current system engineering processes (usability, reliability, systems engineering) and ensure best engineering practices are applied
  • Knowledge of Quality Systems and Regulations impacting the medical device/technology sector

Qualifications:

  • R&D and Engineering with people leadership in a Medical Devices/IVD industry or related field
  • Educated in engineering or science ideally or equivalent work experience
  • Ideally Six Sigma Black Belt or experience of statistical tools application
  • Quality by Design principles and systems (i.e. product requirements analysis, reliability, usability etc.

To find out more about Real please visit www.realstaffing.com

Real 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