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Medical Device Validation Engineer

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The company

Our client is a professional Medical Devices organisation, based in Limburg Netherlands. This international market leader within the Medical Devices industry is continuously growing. They are one of the leaders in technological developments and innovation. They are active within a broad range of industries, and focus on technology and innovation.

Role description

In your role as Validation engineer you will be responsible for the procedures and strategies that are dedicated to provide data within the quality system. You will take the lead in various projects related to computer system validation. You will support the department with validation management involving quality procedures and certain tools that arrive from or need to be implemented in the system. Furthermore, you are involved with internal and external audits where you are the contact person during the process. You will show your expertise by guiding the department in developing software solutions and designs. Finally, you are involved with risk management and change control where you will indicate changes and points of improvement for the QMS. This project is estimated for a period of 1 year with a possibility to extension.

Responsibilities

You will take the lead on site for the computer system validation related projects. You will work closely with various departments from different sites. Furthermore, you are involved with:
• Daily support in maintenance and development of all validated systems
• Monitoring the improvement and development of the computer system validation to MT
• Execution of risk management activities varying from reviews, to performing mitigation activities
• Ensuring compliancy of the system regarding European and US quality standards such as FDA regulations and GAMP 5 principles
• Planning and organizing data, plans and collecting reviews of documentation required for the software development lifecycle process
• Providing expertise in the development of Software structures
• Guiding and giving insights into software validation, compliancy and developing recommendations

Requirements

• Bachelor or Master in engineering
• Minimal of 7 years of experience in an IT function
• Several years of experience within a QA role in the Medical Devices industry
• Experience in working with (software) quality standards such as 21 CFR, ISO 13485, GAMP 5 and preferably Canadian Regulations and Asian standards.
• Providing evidence for the ability for validation and software implementation from multiple projects
• Excellent communicator and team player
• Strong analytical and organizational skills
• Eye for detail
• Fluent in English (written and spoken) and preferably German
• Willing to travel about 50%

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: 03-09-2019
Country: The Netherlands
Region: Limburg
Employment: Permanent
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 UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

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6039 Root
Luzern
+41 (0)43 508 1743

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+31 (0) 20 658 9804

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SIRE Healthcare

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SIRE Human Resources

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SIRE Staffing

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

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