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Quality Assurance Specialist Orthopedics

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Limburg Netherlands. This organisation is an international market leader for orthopedic devices. There focus is to improve people’s mobility by developing innovative and technology-driven devices. Their distribution site in the Venray area is responsible for the EMEA region and they are looking to expand their team with a quality specialist.

Role description

As a quality specialist you are responsible for the quality of the local distribution site. You will be focusing on the Quality Management System according to the ISO 13485 and the ISO 14001 standards. On a daily basis you are involved with the organisation, management and execution of the rework activities. Furthermore, you will take the responsibility to identify non- conformities for the products on the site. You have to make sure that the system is compliant. In addition, you will collect and review required documentation. You are the key contact person when it comes to audits including supplier quality audits, and you will develop and implement improvement processes. Finally, you will give input to the Aftersales team by providing customer feedback and gain insight into product failures.

Responsibilities

• As mentioned previously, your main task is to maintain and improve the Quality Management
System for the Local Distribution site. Furthermore, your overall responsibilities contain:
• Performing internal audits for the ISO 13485 and ISO 14001 standard
• Identifying non-conformities, and performing CAPA’s
• When required execution of validation processes
• Precisely reviewing and documenting failures of the systems, and providing analyses and
implementation strategies to improve the system
• Development and organisation of trainings and the creation of internal quality policies
• Overviewing and guiding calibration procedures
• Key contact person for customers and suppliers regarding quality topics• As mentioned previously, your main task is to maintain and improve the Quality Management
System for the Local Distribution site. Furthermore, your overall responsibilities contain:
• Performing internal audits for the ISO 13485 and ISO 14001 standard
• Identifying non-conformities, and performing CAPA’s
• When required execution of validation processes
• Precisely reviewing and documenting failures of the systems, and providing analyses and
implementation strategies to improve the system
• Development and organisation of trainings and the creation of internal quality policies
• Overviewing and guiding calibration procedures
• Key contact person for customers and suppliers regarding quality topics

Requirements

• Bachelor in Life Sciences or similar years of experience
• Minimal 4 years of experience in a quality role within the Medical Devices industry
• Excellent communication skills in English and preferably Dutch
• Experience with the maintenance of relationships and complaint handling of customers and
other stakeholders
• Extensive knowledge of ISO 13485 and ISO 14001
• Excellent organisational skills and eye for detail
• Experience with Quality System Documentation
• Open minded and team-oriented

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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