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QA Associate

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The company

Our client is a professional Medical Devices organisation, based in Zuid-Holland Netherlands. This organisation is developing products for the medical device sector. Their aim is to help clients by the creation of innovative and highly technological devices. They are operating on an international level varying from the United States, Latin America and Asia.

Role description

Quality is set at a high standard. You will focus on the Quality Control for incoming products for the EMEA region. On a daily basis you are supporting the QA team on inspections, writing reports and execute tests for the materials. You will have an important role to ensure that their devices are compliant on the operational level. In addition, you have an important role for the execution of corrective actions, root cause analyses and product holds. You will become part of a dedicated and passionate QA team where you receive plenty of opportunities for personal and professional development. You will report directly to the associate manager and you will collaborate closely with your team members on both an operational and strategic level.

Responsibilities

As Quality Process Specialist your main responsibility is to be involved with operational and back office QA activities. Furthermore, you are involved with:
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Collecting and creating reports of outcomes from investigations/audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders
• Execution of root cause analyses, risk management and corrective actions

Requirements

• Bachelor in Life Sciences
• Minimal 2 years of experience in an strictly regulated environment in a similar operational role
• Knowledge of ISO 13485 or ISO 9001
• Fluency in English and Dutch business level understanding
• Eye for detail and organizational skills
• Excellent creative thinking and a problem solving mindset
• Team player

Other information

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Juliette van Kraaij


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SIRE Life Sciences®

Ref. number: 47292
Listed by: SIRE Life Sciences®
Listed on: 02-05-2019
Country: The Netherlands
Region: Zuid-Holland
Employment: Permanent
Expertise: 0 - 2 years
Location Type: On location
Education: Bachelor
Language: Dutch
Sector: Medical Devices
Specialisation: 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 Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

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

SIRE Life Sciences UK

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SW1V3PQ London
+44 7307 179882

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