Management Systems Lead Assessor – Medical (Home based)


Management Systems Lead Assessor – Medical (Home based)


Job ID:5421
Location:Houston : 1330 Enclave Parkway (LR_L000269)
Position Category:Assessors
Department:US900051 : LRQA Operations (US900051)
Position Type:Employee Regular
Education Required:See Job Description
Experience Required:See Job Description

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

You’ll perform business assurance assessments and recommend certification, deferral, suspension or withdrawal of certification in accordance with ISO13485, CMDCAS/MDSAP and IVD / MDD management systems standards. You will actively build strong external and internal client relationships.

The outcome of your assessments will result in accurate, insightful reports that will be of real worth to our clients. Meanwhile, you’ll stay focused on your own Continuous Professional Development, actively seeking out opportunities to enhance your expertise and keep your skills fully up to date.

You will:

Have substantial experience as a Lead Auditor in third party auditing/assessment of medical industry clients including system level auditing and process level auditing. Design Dossier/Technical file review for IVD and or MDD devices will be an asset.
Hold a degree or equivalent in a relevant subject. Educational qualifications are likely to be in bio-chemistry, chemistry, biology, material science, polymer science, medical technology or pharmaceutical science.
Have a minimum of 4 years full-time work experience in a medical device related industry; a minimum of 2 years full time practical experience providing experience in an organization designing, manufacturing, testing, or evaluating medical devices.
Possess knowledge and/or experience with test of devices for compliance with standards; performance testing; evaluation studies; clinical studies; knowledge of intended use of medical devices; risks associated with medical devices; relevant product standards.
Possess a high standard of personal presentation, excellent communication skills, both written and verbal, and a flexible attitude.
Have the ability to travel extensively throughout North America, and occasionally overseas if needed.
Be keenly focused on client service excellence.
You will be competent in Microsoft Office suite (Word, Excel, PowerPoint).
Work safely and robustly implement health and safety rules, instructions and systems. Refuse any work that compromises your safety or health.
Promptly report incidents including near miss and safety observations, accidents and injuries. Flag any health and safety concerns with your line manager.

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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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)

How to Apply:

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