Project Quality Engineer Medical

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Date: 11-Mar-2017

Location: Woking, GB

McLaren Applied Technologies is a high-performance technology company which combines fresh thinking and innovation to solve crucial challenges and improve people's lives in industries as diverse as health, public transport, automotive and motorsport.

 

Take the unique opportunity to bring your own ideas to life, whether it’s a software package or a tangible product. If the application for your idea is successful, it will be backed by a significant pledge from the business to fund time and materials costs. Our ambition is that we continue to foster the spirit of innovation and entrepreneurship within Applied Technologies.

 

Role:

To support the growing number projects within the field of medical technology from fitness to health Applied Technologies is looking for experienced professionals in medical technology implementation.

 

The purpose of the role is to embed the quality systems and customers’ needs and requirements into projects within the medical business unit, so that the outputs of the projects meet best practice auditable standard required of the medical technology development.

 

The role will be embedded within projects and take responsibility for developing and delivering the project quality plan. The role requires very close working relationships with engineering and technology teams to ensure the process are implemented to the internal standards as well as identifying opportunities to improve the process to improve efficiency and remove waste.

 

Requirements:

  • To capture the requirement for the project and manage the traceability of the requirements through the development programme to final validation ensuring the project meets the needs of the relevant standards
  • To support continual development of processes to best practice, improving efficiency and minimising waste, in accordance with of ISO9001-2015, and where relevant ISO13485, ISO26262, IEC62304, IEC60601, and ISO14791.
  • 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 manager and reported in Monthly Quality Reviews

 

Work Environment:

You will be based at the world-renowned McLaren Technology Centre. Our campus includes a subsidised restaurant, a café, a gym with a pool, break-out spaces, bicycle storage facilities and more.

 

Our environment is designed to encourage collaborative working across all teams. You will be within one hundred metres of a specialist within their field, whether it’s in design, modelling and simulation, software development, data analytics, electronics hardware, finance, and marketing.

 

Skills 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

 

Recruitment Process:

  • If your application is successful, you’ll be invited for a phone interview with one of our experienced technical recruiters.
  • If our recruiter believes you’re suitable for the role, you will then be invited to a telephone interview with the manger
  • The final stages will include a face to face interview at the McLaren Technology Centre in Woking, Surrey which may include a practical exercise

 

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