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Management Systems Assessor - Medical Devices - US

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Date: 22-May-2019

Location: Birmingham, GB

Company: Lloyds Register

Job ID:28166
Location:Birmingham : 1 Trinity Park : Bi (LR_L000100) 
Position Category:Assessors
Department:GB115003 : LRQA QMS Assessors (GB115003)
Position Type:Employee Regular
Education Required:See Job Description
Experience Required:See Job Description
Relocation Provided:Yes

 

Re-location - This position is based in the USA - Various Locations 

 

 

Lloyd’s Register moves with the times. With 250+ years of industry-defining excellence behind us, we’re more committed than ever to meeting the challenge of setting today’s global standards. We’re a truly global organisation, working in global teams to help global clients manage and overcome global safety risks. And setting global standards of excellence brings fresh challenges every day – giving our people more access to work that interests them personally and stretches them professionally. If you have the ambition and international mind-set to match ours, there’s no telling how far you can go here.

 

As an established Notified Body for both the Medical Devices and In vitro Diagnostic Medical Devices Directives, we are looking to recruit a full-time assessor open to the opportunity to support our United States clients.

 

This role would require relocation to the United States and would support our existing activities in the in vitro diagnostic medical devices field. The main responsibilities will be to perform assessment against the requirements of ISO 9001, ISO13485/MDSAP and the In vitro Diagnostic Medical Devices Directive. 

 

 

You will:

 

  • Contribute to securing for the benefit of the community high technical standards of design, manufacture, construction, maintenance, operation and performance for the purpose of enhancing the safety of life and property at sea and on land and in the air
  • Build positive relationships with our clients to generate client satisfaction and ensure long term business growth
  •  Act as assessment Team Leader, planning and carrying out assessments to meet agreed service delivery expectations.
  • Maintain high standards of behaviour, taking responsibility for personal development, balancing work, safety and life priorities
  • Collaborate with internal and external stakeholders to ensure our assessment services are delivering, valued added support to clients and meeting all accreditation requirements 

     

     

    To be considered:

     

  • Necessary medical device experience to meet LR competency requirements for 3rd party assessors
  • Good engineering or scientific background and demonstrate a thorough understanding of management systems within the medical device sector
  • A degree (or equivalent qualification e.g.. HND and or associated experience) in a relevant subject such as engineering or science
  • Understand of the legal and regulatory framework and requirements of the sector
  • A thorough understanding of the application of ISO 13485, MDD, and ISO 9001 based management systems, and experience with or management of second or third-party auditing/assessment, including system level auditing and process level auditing
  • In addition, experience working for Certification Bodies and or within a variety of sectors would be a distinct advantage

 

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The Lloyd's Register Group comprises charities and non-charitable companies, with the latter supporting the charities in their main goal of enhancing the safety of life and property, at sea, on land and in the air - for the benefit of the public and the environment. (Group entities)

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