Quality & Regulatory Manager

Bedrijfsnaam: -
Plaatsingsdatum: 23/09/2018
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 Gelderland Netherlands.The CompanyThis organisation is a wholesaler and manufacturer of urological devices. Their Headquarters are situated in Asia and from there they operate internationally with their biggest sites in the US and the Netherlands. They offer a wide range of products and they experience continuous growth.

Role DescriptionAs a Quality Manager you will gain full responsibility of the Quality Management System, related activities and regulations on the local site. You will take the lead when it comes to Quality and Regulatory 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. You will closely collaborate with the HQ and site in the US. Furthermore, you are also responsible for creating awareness and taking initiatives regarding quality within the organisation.

ResponsibilitiesYour 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 international stakeholders 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 Life Sciences
• Minimal 6 years of experience in the Quality Field
• Knowledge of regulations and documentation such as the MDD/MDR
• Preferably experience with regulations in China and Japan
• Excellent knowledge of ISO 1348: 2016
• Excellent organizational and problem-solving skills
• Extensive experience with FMEA, CAPA’s, and risk management
• Experience in leadership
• Fluency in Dutch and English
• Strong in communication skills

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 :
5 - 10 jaar
Contactgegevens :