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 Gelderland Netherlands.
The company is a medical device company and develop high tech devices and solutions for the Medical Device Market. Their products enable medical professionals to work more efficient and effective to improve patient satisfaction.
ROLE DESCRIPTION
As the new Quality Assurance Manager you will be solely available for all QA and partly RA processes. Your main task is to update and improve all Management Systems of the company and assuring all processes to be compliant to all standards that concern the company. You will do this in cooperation with other teams but will be solely responsible for the QMS.
RESPONSIBILITIES
You will be responsible for implementing and maintaining the QMS, safeguarding the quality of all processes concerning towards standards as ISO 9001, ISO 13485, MDD etc. Other responsibilities would be:
• You will manage all process complaints and report/discuss to concerning teams and/or directors
• You will be in close contact with the RA Manager and will when needed work together/take over RA tasks
• Making sure that all processes are in line with future standards and will conduct continuous analysis to safeguard this compliancy
• Will lead audits internal and external
• Maintain and where needed raise awareness of QA within the company and give courses to teams where knowledge is insufficient
REQUIREMENTS
• A degree in Quality Management or similar is a big pre
• At least 3 years’ experience in a management function, a production environment is a big pre
• Proven knowledge of current and new Medical Device standards such as ISO 9001 & 13485, MDD and FDA
• Able to be a decision maker who can rationalize and be independent
• Experience in audits
• Excellent skill in Dutch and English both 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 Jeroen Evertsen.
