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Auditor Medical Devices

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The company

Our client is a professional Medical Devices organisation, based in Antwerpen Belgium. This company is looking for excellent auditors. They are an international organisation that provides certifications for Life Sciences companies. As quality and regulations become more strict and complex, they are looking for some new employees.

Role description

In this particular job as auditor for the Medical Devices, you will visit organisations where you will certify their quality management systems. You will perform the audits according ISO 13485 standards and European regulations. You will be giving advice and coordinate certification procedures for clients. From time to time you will visit clients abroad.

Responsibilities

You will receive the responsibility to ensure compliancy of the QMS from other companies. Furthermore, your tasks involve:

• Guiding organisations with the implementation of regulations and adaptations of the QMS
• Offering assistance in ensuring that the client is following up on the correct changes within the regulations and standards
• Helping out the company with further developments in relation to the assessment of medical devices and/or environmental management systems.

Requirements

• Bachelor or Master in Life Sciences
• Minimal 5 years of experience in the Medical Devices industry in both manufacturing and distribution environments
• Excellent knowledge of GMP, ISO 13485, 21 CFR Part 820
• Great knowledge of relevant regulations from the European and international markets (such as FDA and CE- marking)
• Excellent analytical and problem-solving skills
• Fluency in English, Dutch and business level French
• Strong in communication skills
• Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
• Individual operator yet team player

Other information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.


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SIRE Life Sciences®

Geplaatst door: SIRE Life Sciences®
Geplaatst op: 17-06-2019
Land: Belgium
Regio: Antwerpen
Dienstverband: Permanent
Expertise: 6 - 10 jaar
Locatie Type: Op locatie
Opleiding: Master
Taal: Engels
Sector: Medical Devices
Specialisatie: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277