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Technical Specialist - Medical devices

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Date: 15-Feb-2019

Location: Birmingham, GB

Company: Lloyds Register

Job ID:10205
Location:Birmingham : 1 Trinity Park : Bi (LR_L000100) 
Position Category:Technical
Department:GB115009 : LRQA Medical Directives Team (GB115009)
Position Type:Employee Regular
Education Required:See Job Description
Experience Required:See Job Description
Relocation Provided:No

 

 

Role Purpose:

 

To manage internal and external management systems technical compliance, effectiveness and improvement within defined remit, and to develop and coach others to support the delivery of business assurance services.

Specific working knowledge of Cardiovascular  devices preferably including heart valves  and their technical file or design dossier and clinical evaluations requirements

 

You will:

 

  • Provide technical support within defined area of expertise to ensure consistency of interpretation and application to service delivery processes
  • Undertake Design dossier and Technical file reviews for Cardiovascular devices
  • Responsible for managing technical knowledge within defined remit to ensure a high standard of service delivery
  • Monitor technical knowledge and interpretation (eg through accompanied visits, internal audit, technical review, stakeholder feedback, coaching, formal training, or other appropriate development mechanism), reviewing complaints and providing feedback as appropriate in order to support professional development
  • Where appropriate, participate in the recruitment of Assessors Review Assessor competencies for specific industry/business sectors and authorise the allocation of codes, consulting with colleagues as appropriate
  • Within remit, monitor new and updated standards, accreditation/oversight rules, legislation, codes of practice etc, disseminating information via the most appropriate media Representing LRQA on appropriate external committees and forums, taking every opportunity to build LRQA’s brand and reputation in the industry
  • Contribute to internal debate on future regional/global developments within area of technical expertise  Lead and manage the improvement of existing products and the development of new products
  • Undertake certificate decision review of client visit & technical reports as appropriate, authorising approvals, suspensions  and withdrawals of approval
  • Organise, prepare and run technical meetings, involving other LRQA managers and experts as appropriate, and ensuring that an opportunity is created for participants to learn and build engagement.
  • Have sufficient broad knowledge of LRQA’s products and services to able to discuss additional services with clients and be able to take the opportunity to promote additional or higher value services.  Actively participate in duty manager rota from agreed office location and provide technical support to the business centre.
  • Using developed knowledge and experience to support sales functions with enquiries and technical requirements, so that LRQA can respond within 5 working days

 

To be considered:

 

  • Expert technical knowledge of appropriate industry sector and relevant legal/regulatory framework
  • Qualification in business improvement tool(s) is desirable
  • Extensive knowledge of LRQA products, processes and systems and an understanding of LRQA’s competitive advantage
  • Experience of delivering training would be an advantage
  • Commercially astute, can effectively balance technical integrity and commercial viability
  • Degree or equivalent and ideally chartered professional status (eg CEng CQP, CEnv) and also meets the education, experience and competence requirements for Lead Assessor registration with IRCA (or equivalent) and have operational knowledge of the core LRQA services
  • An excellent verbal and written communicator who is able to convert complex processes into simple procedure, outcome and behaviour statements
  • Able to gain agreement to ideas through influence and persuasion, is confident and assertive and respected by assessors and technical managers
  • Knowledge and experience of process and people performance monitoring and measuring systems
  • A thorough understanding of the concepts of Business Assurance and risk based assessments

 

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