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13485/MDSAP - Lead Assessor

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Date: 08-Aug-2019

Location: Houston, TX, US

Company: Lloyds Register

Job ID:28912
Location:Houston : 1330 Enclave Parkway (LR_L000269)
Position Category:Assessors
Department:US900051 : LRQA Operations (US900051)
Position Type:Employee Regular
EducationRequired:See Job Description
Experience Required:See Job Description

Management Systems Lead Assessor (Medical sector)


Bring your management systems audit skills and medical device industry experience to our Management Systems Lead Assessor role and make the most of your professional skills doing more of the work you enjoy.


Setting international standards of excellence in safety is our purpose as an organization. Responsible, dedicated Assessors like you help our clients to manage their systems and risks so they can improve their current and future performance. Join our global assessment team and be inspired by your work.


About the role


As an established Notified Body for both the Medical Devices, we are looking to recruit a full-time assessor to support our existing activities in the 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.


Qualification and experience requirements


You will be able to demonstrate a comprehensive understanding of in vitro diagnostics R&D, manufacture and QC testing, ideally with both NAT and immunoassay technologies. Knowledge of the clinical pathology applicable to the conditions or disease states being diagnosed is essential, as is a general understanding of the regulations and standards applicable to the IVD industry.


A minimum of a first degree in a relevant science subject, as well as relevant postgraduate experience gained within the IVD industry, a clinical laboratory or medical research institution, is important and quality assurance experience would be an advantage. You should also possess a high standard of personal presentation, excellent communication skills, both written and verbal, and a flexible attitude. This will be supplemented by the ability to exercise good judgment and make sound decisions with reasoned argument whilst under pressure.


The position is home-based but will involve extensive travel, mainly throughout the US and occasionally abroad.


About us


Join Lloyd’s Register and enhance your reputation as you maintain ours. In sectors ranging from food safety to energy management, our work helps to make sure our clients’ assets and processes are safe, dependable and sustainable.  After over 250 years, we remain a driving force for innovation and excellence; giving you more access to work that interests you personally and stretches you professionally. How will you build on our legacy and help our clients succeed?


Help write a new chapter in our story of excellence.  


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