Supplier Quality Engineer

Location: Netherlands

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 Noord-Brabant Netherlands.

The Company

They are a professional Healthcare and Medical Devices and operates at an international level. They are one of the leaders in technological developments and innovation.

Role Description

As mentioned you will become part of a dynamic and technology- driven business setting. On a daily basis you will interact with suppliers to check on the maintenance and efficiency of the QMS. Furthermore, you are involved with the development and improvement of quality standards for the organisation’s suppliers. Your aim is to improve the quality system in which you are supported by internal and external stakeholders. In particular, you will identify points of improvement that are related to supplier quality system, and which are in line with Corporate, International and European documentation and legal principles. You have a crucial role for the execution of supplier audits and will assist the entire procedure. You are the point of contact when it comes down to questions about and/ or discrepancies within QMS. This project is set for a year and has possibilities for extension.

Responsibilities

As a Supplier Quality Engineer, you are responsible for the supplier Quality Management System in general. You will receive the responsibility to maintain, asses and improve the QMS, and keep on track of relevant changes and specifications applicable to the system. Furthermore, your role includes:
• To be aware 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 the FDA, IMB and notified bodies
• Constantly analyzing the supplier data and processes to trace risks and identify improvements.
• Maintenance of relationships with both internal and external stakeholder
• Keeping on track with the KPI’s of the supplier department
• Maintenance of supplier lists on a local and international level

Requirements

• Bachelor in engineering
• Minimal 8 years of experience in an engineering role
• Minimal 4 years of experience in a strongly regulated environment, preferably the Medical Device Industry
• Excellent knowledge of ISO 13485, 21 CFR Part 820, 803, 806, ISO 9001, and ISO 14971
• Great knowledge of European Medical Devices Regulations and Japanese regulations
• Excellent analytical and problem-solving skills
• Experience with FMEA, CAPA’s, and root cause analysis
• Fluency in English and Dutch
• Strong in communication skills
• Certificate for auditor for the ISO 13485 and preferably CFR 820
• Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
• Individual operator yet team player

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.