Experienced Quality EngineerExperienced Quality Engineer

Bedrijfsnaam: -
Plaatsingsdatum: 07/02/2019
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 Pharmaceutical and Medical Devices organisation, based in Limburg Netherlands.The CompanyThis multinational is providing healthcare solutions for various industries such as cardiology, orthopedics, and urology. Their business culture focuses on innovation, passion and collaboration across the world.

Role DescriptionAs an experienced Quality Engineer, you are involved with the quality system and related 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. Furthermore, you are also responsible for creating awareness and taking initiatives regarding quality within the organisation. This involves collaboration with stakeholders from different departments such as R&D and Sales.

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
• Taking the lead in the execution of internal and external audits
• Ensuring compliancy for both Quality and Regulatory principles according to the FDA, IMB 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 engineering
• Minimal 5 years of experience in the Quality Field
• Minimal 2 years of experience in the Medical Device Industry
• Excellent knowledge of ISO 13485 and 21 CFR Part 820
• Excellent organizational and problem-solving skills
• Experience with FMEA, CAPA’s, and root cause analysis
• Fluency in English and Dutch
• 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 Ewout de Jong.




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