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 companyOur client is a professional Medical Devices organization, based in Netherlands. This client is an international player which offers a broad range of products for both humans and animals. Their aim is to improve health conditions across the globe.Currently, they experience a remarkable growth and therefore, they are looking to expand their organisation in various countries.
Role descriptionQuality in this organisation is set at a high standard. In your role as Quality Assurance auditor you will gain the responsibility to execute audits both at an internal and external level. You will get a flexible and dynamic position within the organisation as you will travel frequently to the subsidiaries within Europe. You will gain an advisory role in which you take the lead for GMP audits. You will maintain relationships with the various stakeholders at the site. This includes collecting and organizing required documentation, consistently reporting all points of improvements and developments, and finally checking the coherence between the product specifications and international legislation. This role is set for 4 months with a possibility to extend for 2 months.
ResponsibilitiesAs mentioned previously, you are the contact person when it concerns audits. You will be in charge of the required documentation, planning and execution. Next to that, other major tasks involve:
• Planning and organisation of internal and external audits, which involves our guidance throughout the entire process
• Assessment and identifying points of improvement from reports conducted throughout audits
• Keep on track with the changes and developments within the industry, including relevant legislation and regulations on an international scale
• Maintenance of relationships involving internal and external stakeholders among which departments across the organisation, notified bodies, and other
Requirements• Bachelor of Science
• Minimal 2 years of experience as auditor within Medical Device company
• Minimal 4 years of experience in strongly regulated industry
• Excellent knowledge of FDA and European standards
• Experience in Lean six-sigma belt
• Strategic planning and organisation skills
• Strong communication and negotiation skills
• Fluency in English and Dutch
• Pro-active and flexible attitude