Now they are looking specifically for an auditor for the medical device market to audit their client and make sure that Quality Management Systems and Regulatory documents are implemented according to all guidelines and ensure the coordinatino of certification procedures.
Role DescriptionCurrently they are looking specifically for an auditor for the medical device market to audit their clients and support/assure that the Quality Management Systems and Regulatory documents are implemented according to all guidelines. Your office will be located in Antwerp but you will be working mostly homebased, and from there meet with clients in your area.
Responsibilities- You will audit compliance with ISO 13485 and CE marking regulations (Assessment of Conformity EC Directive 93/42/EEC) for medical devices as well for any other quality assurance systems for which you are qualified - You will present our certification services to potential clients and ensure the coordination of certification procedures - You will provide assistance for the implementation of new guidelines regarding accreditations - You will provide assistance for the development and implementation of our regulations in the field of certification - You will provide assistance for the further market development of our services for the assessment of medical devices and/or labour & environmental management systems - You may occasionally be required to carry out an assignment abroad
Requirements- You have a university or higher non-university qualification (e.g. Industrial Pharmacist, etc.) - You have at least 5 years of relevant professional experience in the medical or paramedical sector or as a safety & environmental manager - You have a thorough knowledge of the relevant legislation - You also have an in-depth knowledge of systems such as ISO 13485 - You have excellent interpersonal and communication skills at all levels - You have a good command, both verbal and written, of Dutch, French and English - You like to work in a meticulous manner and have good organisational skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.