Project Quality Engineer Medical

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Date: 10-Feb-2017

Location: Woking, GB

We take performance beyond what was thought possible, working with visionaries and leaders to move our world forwards faster.

 

McLaren Applied Technologies, part of the McLaren Technology Group, innovates using the skills, insights and experience gleaned from over 50 years of competition in the world’s most technologically demanding sport, to innovate in and also beyond motorsport. We seek to create meaningful, long-lasting performance gains that positively impact a variety of sectors and communities.

 

With a passion for performance excellence, we bring together a distinctive combination of technology, mindset and capabilities - including high performance design, analytics, simulation, sensing and control systems – to make innovation a reality for our partners.

 

Our people are dynamic with excellent technical and commercial skills.

 

We partner with world leading businesses across many sectors; what unites us is a desire to prevail in whatever we do. Together we strive to be the best or to go beyond what was considered to be the limit of performance.

 

Purpose of the Role:

To support the growing number projects within the field of medical technology from fitness to health Applied Technologies is looking for experienced experts in medical technology implementation. Initially this expertise would be used to establish, implement and maintain a quality system in accordance to ISO13485 and 21 CFR 820. The engineering life cycle processes for medical products needs to be developed and aligned with existing automotive processes and should follow best practice medical safety standards and risk management. The role ensures that our process will meet to auditable standards the lifecycle development requirements of ISO13485, ISO14971 and IEC60601, IEC62304, IEC62366, 21 CFR 820 and the guidance documents by FDA. The role will be responsible for an initial gap analysis between the existing processes and the range of applicable standards, make recommendations on the improvements required and implement process updates.

In the medium term the role will develop into an embedded role within projects, implementing the processes with best practice templates and checklists. The individual will liaise with the engineering teams to ensure that the processes continually develop and align to the high level business process and are compliant to the standards which will allow McLaren Applied technologies to successfully and efficiently produce products and services for motorsport, transport, automotive, medical and strategic partnerships business units. As the role matures the individual will take a leading role in future medical technology projects owning the project quality plan and will work on further improvements of the process together with his/her colleagues.

 

 

Principal Accountabilities:

 

  • To capture the requirement for the new development process through understanding of the relevant standards and discussions with the development teams (e.g. HW, SW, industrial design, system engineering, operations)
  • To ensure the requirements are reviewed and agreed with the chief engineer, technology leaders and Head of Quality
  • To deliver the top level development process as an as approved business process document.
  • To write the sub processes, outlined in the main development process, that cover the ways of working, and allows process to meet the requirements of ISO9001-2015, and where relevant ISO13485, ISO26262, IEC62304, IEC60601, and ISO14791.
  • Ensure the process development aligns to the overall project development framework and other business systems, where system is in need of development to meet the required standards this should be highlighted.
  • Builds relationships internally with product owners and technical leaders to act as credible voice quality in the process development.
  • Will input into the Maintenance and Development of the QMS, to ensure the processes align to the overall Quality Management Systems
  • Leads and Supports, FMEA, FTA and Risk Analysis within own projects and act as an independent voice for other projects
  • Championing Customer’s needs through the project life cycle. Accountable for capturing the customer requirements and ensuring the technical requirements, risks and parts are managed, validated and approved in the development and reviewed in the success phase.
  • Accountable for defining and verifying the Requirements for the Project Milestones and Gates, and ensuring open items and risks have clear resolution plans
  •  Responsible for Planning and Implementing Project Quality activities, ensuring Quality is managed throughout the project, supporting the project manger and reported in Monthly Quality Reviews

     

     

     

     

    Knowledge, Skills, Qualifications and Experience:

  • Strong engineering background, in HW, SW or mechanics with directly relevant experience in developing medical products
  • Experienced in Project Quality Planning, and/or Project Management with a history of developing project processes and successful project delivery
  • Experience of building effective close working relationships both internal and externally to influence quality culture and challenge ways of working.
  • Demonstrated strong written and verbal communication in a challenging environment from engineering to Senior/Executive Level
  • Developed quality management systems, with experience of implementing or auditing to ISO9001:2015, and ISO13485. Experience of ISO26262, ISO14791, IEC 60601, IEC 62304, IEC 62366; 21 CFR 820 would be an advantage
  • Engineering degree or equivalent
  • Strong Analytical Approach, with an understanding of metrics required to justified, actions
  • Understand of best in class quality practices and commercially focused application.
  • Recognised Project Management Qualification (e.g. Prince2, APMP, PMP) would be an advantage

     

     

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