Quality Management Systems Manager
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!
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
is a developer of Medical Devices in various domaines (imaging, diagnostics, consumer good, etc)
I am looking for a contingent worker in the area of Document & Record control with experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment. Management reviews and record control are one of your key tasks within this role.
- Collects and maintains documents & records of the latest revision level.
- Timely distribution of latest revision level documents & records to all appropriate users and ensures that obsolete documentation is removed from distribution / publication.
- Maintains the document management system and ensure fast retrieval of documents & records.
- Controls issuance of document numbers, including maintenance of proper document registers.
- Ensures proper document classification, sorting, filing and proper archiving.
- Reviews completeness of documentation and prepares document transmittals.
- Ensures that all controlled Quality documents are maintained to the latest issue, and that these documents are made available at all locations where operations essential to the effective functioning of the Quality Management System are performed.
- Ensures that all obsolete documents shall be withdrawn if retained for record purposes.
- Leads and supports (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel.
- Setting up management reviews
- 3 to 5 years related experience in change control and/or document control field
- Familiarity with Document Management System tools
- Experience running effective process improvement projects
- Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR and ISO 13485
- Preferred Qualifications:
Prior group or team leadership experience.
Procedural or Technical writing experience.
Understanding of modeling tools.
- Awareness of Project Management Institute standards.