Freelance QA manager

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Medical Devices organization, based in Gelderland Netherlands.

This organisation is supporting medical device manufacturers within the Medical Devices industry. They are based in the Netherlands, Asia and the United States. Their scope is on providing advice and support for these international manufacturers regarding quality standards and regulations. As Quality and Regulatory requirements become more demanding, they see their number of customers increasing.

ROLE DESCRIPTION

In your role as QA manager, you will be taking the lead for improvement and development of the quality system. You will be directing a team of professionals that support you to reach this goal. On a daily basis you will control and gather all required documentation and legislation regarding the ISO 13485 standards. Furthermore, you will be a key person when it comes down the establishment and maintenance of relationships with other teams and the manufacturing site. It is the responsibility of you and your team to exchange knowledge and information with involved parties regarding Quality Assurance standards and related procedures. This project is set for 4 months and can be extended with 2 additional months.

RESPONSIBILITIES

As mentioned previously, in your role as Quality Assurance manager you will be taking the lead and guide your team in providing knowledge and overviewing the activities. Furthermore, your responsibilities include:
• Ensuring continuous improvement of the Quality Management System
• Key contact person for issues regarding QA and RA medical devices for internal and external stakeholders
• Being on track of all developments and changes regarding European, American and Asian regulations and ISO standards
• Taking the lead in internal and external audits on manufacturing sites
• Providing and developing trainings and related documentation both for customers and colleagues

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal of 6 years of experience in QA position within the Medical Devices sector
• Minimal 3 years of experience with leadership and/or management role
• Excellent knowledge and understanding of ISO 13485 and related procedures
• Broad knowledge and understanding of European, American and Asian legislation and regulations of the Medical Devices industry
• Strong communication and analytical skills
• Decisive leader and team player
• Fluent in both Dutch and English

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.