Quality & Regulatory Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 23/10/2018
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Zuid-Holland Netherlands.The CompanyOur client is an international, innovative organisation that is represented in various industries varying among food, pharma and medical devices. They are an dynamic and offer a challenging environment.

Role DescriptionYou 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 quality 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.

ResponsibilitiesOn 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 and ISO 9001 standards
• Providing 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, preferably in chemistry
• Minimal 4 years of experience with QA on a production site within the Medical devices or Pharmaceutical industry
• Proven experience with the maintenance and improvement of QMS
• Experience with audits and inspections of notified bodies and other authorities
• Excellent knowledge of American and European legislation and regulations
• Fluent Dutch language and business proficiency English
• Critical scope and excellent analytical skills
• Team player, yet individual operator

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :