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Senior QA Specialist

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Gelderland Netherlands. This organisation focuses on creating highly innovative and technology-driven products. They are responsible for the development and production of technical medical systems that are intended for the cleaning and disinfection of endoscopes. They have great ambitions and are therefore looking to expand their organisation.

Role description

You will become part of an informal and dynamic business setting in which quality is set at a high standard. You will receive various responsibilities that are directed to maintain and improve the Quality Management System. In addition, you are responsible for the ISO 13485 standards and required documentation. You will be the key person to contact whenever there are any issues or questions about the Quality system, ISO standards and required documentation. Furthermore, you will gain insights into improvements and developments for the QA department. This project is set for 6 months with possible extension to a year.

Responsibilities

On a daily basis you are involved with overviewing and maintenance of the Quality Management System. In addition, on a daily basis you are involved with:
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Gain insight into possible points of improvements for the QMS according to ISO 13485 standards
• Providing advice and support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• You will be on track with the latest developments and changes of QA within the Medical Devices sector, involving
regulations & legislation such as the MDR and FDA

Requirements

• Bachelor in Life Sciences
• Minimal 4 years of experience with QA on a production site within the Medical devices industry
• Minimal 2 years of experience in an strictly regulated environment
• Proven experience with the maintenance and improvement of QMS
• Excellent knowledge of American and European legislation and regulations
• Fluency in English, and good understanding of the Dutch language
• Critical scope and excellent analytical skills
• Team player, yet individual operator

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: Gelderland
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Medical

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Contact

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