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Experienced Quality EngineerExperienced Quality Engineer

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Limburg Netherlands. This multinational is providing healthcare solutions for various industries such as cardiology, orthopedics, and urology. Their business culture focuses on innovation, passion and collaboration across the world.

Role description

As an experienced Quality Engineer, you are involved with the quality system and related activities. On a daily basis you will assess and review the Quality Management System to see if there is need for any changes and/or improvements. You will be a key contact person when it comes down to questions or issues related to Quality for both internal and external stakeholders. Furthermore, you are also responsible for creating awareness and taking initiatives regarding quality within the organisation. This involves collaboration with stakeholders from different departments such as R&D and Sales.

Responsibilities

Your priority will be the maintenance and improvement of the QMS. Further responsibilities involve:
• Maintenance of the internal and external regulations including ISO qualifications.
• To overview processes and applications conducted by your team which includes supplier containment, CAPA’s , Document control, and risk
management
• Taking the lead in the execution of internal and external audits
• Ensuring compliancy for both Quality and Regulatory principles according to the FDA, IMB and notified bodies
• Constantly analyzing data and processes to trace risks and identify improvements for the Quality Management Systems.
• Maintenance of relationships with both internal and external stakeholders

Requirements

• Bachelor in engineering
• Minimal 5 years of experience in the Quality Field
• Minimal 2 years of experience in the Medical Device Industry
• Excellent knowledge of ISO 13485 and 21 CFR Part 820
• Excellent organizational and problem-solving skills
• Experience with FMEA, CAPA’s, and root cause analysis
• Fluency in English and Dutch
• Strong in communication skills

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®

Listed by: SIRE Life Sciences®
Listed on: 06-02-2019
Country: The Netherlands
Region: Limburg
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
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 Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Engineering

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Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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