Quality Auditor- Multiple Positions x10

Recruiter
ProClinical Ltd
Location
London (Greater)
Posted
02 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
ProClinical is currently seeking 10 Quality Auditors for a range of positions within a medical technology and devices company. Below is a list of the general requirements the ideal candidate would possess and specific requirements based on the varying areas of work.The Notified Quality Auditor ensures that organizational processes – and the goods and services that result – comply with the requirements of standards (e.g., AS9100, ISO 9001, ISO13485), as well as customer, regulatory, and the organization’s own requirements. There are Multiple Positions Available.General Experience Required:A minimum of four years of full-time hands-on work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research), including at least two years in the area of quality management. Full time hands-on direct work experience can be in one or more of the following: * Research and development, manufacturing, service; * the application of the device technology and its use in health care services and with patients; * testing the devices concerned for compliance with relevant national or international standards; * conducting performance testing, evaluation studies or clinical trials of the devices. A minimum of degree level qualifications relevant to medical devices and your hands-on work experience (electrical, mechanical or bioengineering / biology or microbiology / chemistry or biochemistry / computer and software technology / human physiology / medicine / pharmacy / physics or biophysics) EMEA Medical Device Assessor - Active & Passive Devices x 2 A minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on Active Devices as well as Passive Metal and Plastic devices. For this role this would need to be in Electrical / Electronic Engineering or a closely related subject. EMEA Microbiology Assessor A minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on cleanroom technologies, sterilisation methods and facilities, associated ISO standards for cleanroom and sterilisation methods and analysis. You'll also have working knowledge of ISO13485 / ISO14971 and Medical Devices Directive. In addition hold a Microbiological Degree or similar qualification. *Just having Micro experience isn’t enough, we need them to have had some exposure to Active, passive, or software devices. EMEA Medical Devices Assessor - Active & Software Devices A minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on Active and/or Software medical devices. In addition, a minimum of degree level qualifications, or equivalent, relevant to medical devices. For this role this would need to be in electrical and/or computer and software technology. EMEA Medical Devices Assessor - Active & Passive Devices A minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on Active Devices as well as Passive Metal and Plastic devices. For this role this would need to be in Electrical / Electronic Engineering or a closely related subject. EMEA Medical Devices Assessor - Active & Software Devices A minimum of four years of full-time 'hands-on' work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) which will include at least two years in the area of quality management. This experience must be focused on Active and/or Software medical devices. In addition a minimum of degree level qualifications, or equivalent, relevant to medical devices. For this role this would need to be in electrical and/or computer and software technology.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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