Quality Assurance Manager

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

This organization offers custom-made solutions for people with mobility issues. They are a manufacturing and distribution site.

Role Description

In your role as Quality Assurance manager, you are responsible for a team of ambitious and dedicated quality experts located at two locations. In collaboration with your team, you will make sure that the QMS is compliant and that all required documentation is controlled, involving variations of legislation for the EMEA region. On a daily basis you are responsible for overviewing the Quality strategies and procedures. This concerns creating company strategies and exchange your knowledge across other departments within the company. You will frequently have consultations with the European Quality Director and the VP Quality & Operations. Finally, you will remain contact with internal and external stakeholders such as notified bodies, distributors and end clients.

Responsibilities

On a daily basis your major job is to overview the QA, in which you guide your team members and collaborate to improve the Quality department. Furthermore, you are involved with:
• You are responsible for a team of QA inspectors and engineers
• On a daily basis you will support and guide the team and overview the QA procedures
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Overview and collect required documentation and legislation in relation to the product specifications
• Review and assessment of procedures involving risk and validation management at the manufacturing site
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• You will be on track with the latest developments and changes of QA within the Medical Devices sector
• Establishment and maintenance of relationships with departments and external stakeholders on a global level
• You will negotiate across the company with various parties on behalf of the QA department

Requirements

• Bachelor in Life Sciences or equivalent experience
• Minimal 3-5 years of experience within QA in a strongly-regulated environment, preferably food or medical devices
• Excellent knowledge of quality standards such as ISO 13485, GMP, ISO 14001, ISO14971
• Knowledge of EU and US regulations preferably the MDD and MDR
• Excellent leadership and organisational skills
• Fluency in Dutch and English
• Strong communicator and analytical skills
• Critical Scope
• Team Player

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Juliette van Kraaij