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Freelance ISO 13485 Auditor

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Date: 25-Dec-2020

Location: Hong Kong, HK

Company: Lloyds Register

Job ID:31520
Location:Hong Kong : Hopewell Centre (LR_L000348) 
Position Category:Assessors
Department:HK610050 : HKG-MGMT SYSTEMS (HK610050)


The Freelance Auditor will be providing ISO 13485 and ISO 9001 audit and training services to our clients.


Key Responsibility: 
• To undertake client management activities for assigned clients 
• To lead or participate in various type of assessments including preliminary assessments, initial assessments, follow-up visits, surveillances and certificate renewals to contractual agreement requirements
• To produce verbal and written assessment reports on time and to the agreed format
• To identify new and potential business opportunities, advise clients on LR and LRQA services and action any resulting leads
• To lead or participate in special projects


The successful candidate will have:
• Degree holder in : biology, microbiology, chemistry, biochemistry, computer/software technology, electrical, electronic, mechanical engineering or bioengineering, human physiology, medicine, pharmacy, physics or biophysics
• ISO 13485 lead auditor  
• Over 4 years work experience in a medical device related industry, including two years in one or more of the following: research & development, manufacturing, application of the device in a clinical setting, testing of devices for compliance with standards, conducting performance testing, evaluation studies, clinical trials.
• Hold CCAA, IRCA or other equivalent assessor registration qualification 
• Prefer hold IRCA trainer registration qualification or other equivalent (preferred)
• Chinese (Cantonese and preferred with Mandarin) and English speaking and writing skills
• An enthusiastic and committed team player


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