Quality Auditor

Location: Belgium

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Antwerpen Belgium.

The Company

They are responsible for auditing and certificating Life Science companies to make sure the market is compliant with the (inter)natioal laws. They have a well established client list that is growing every year and is currently a world leading inspection, verification, testing and certification company. Specifically in Belgium, they certify quality systems, as well as safety management systems, environmental management systems and operational food safety systems.

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 Description

Currently 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