Quality Assurance Manager
Location: NetherlandsSIRE 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 Zuid-Holland Netherlands.
They are an innovative Dutch company that specializes in the development, production and sales of micro surgical instruments.
ROLE DESCRIPTION
As a quality assurance specialist you’ll be in a very alternating position in a professional, innovative and ambitious organization. Your main responsibilities will be to deploy, assure and monitor their quality policies. Apart from that, your will be organizing, managing, maintaining and continuously improving of their quality management systems conform the international regulations for manufacturers of Medical Devices.
RESPONSIBILITIES
You will be deploying, securing and monitoring of the quality policies. Organizing, managing, maintaining and continuously improving of their quality management systems. You will be supporting and advising at entering new and improved products into the market. With that, you will assure that they comply with applicable international regulations.
• Implementing and monitoring internal and supplier audits, Independently and in teams
• Coordination and follow up of extern audits
• Initiating and monitoring the progress of corrective and preventive actions
• Preparing, measuring and releasing of several documents
• Quality control and releasing of produced products
• Active supporting of the operational department
• Accompany the projects that we place out and giving them advice
REQUIREMENTS
• MSc/BSc thinking and working level
• +- 5 years of Medical Devices QA working experience
• Provable experience and knowledge with the actual medical devices laws and regulations, in Europe, the US and Japan. As well as the ISO-standards.
• Certified lead auditor ISO13485
• Knowledge in Cleanrooms
• The ability to plan- and work independently and coach and develop teams
• Strong communicative skills, spoken and written
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rombout van Rees.
