Quality Specialist
Location: GermanySIRE 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 .
They are an international Medical Device manufacturer and currently looking for a new specialist to support them in the Cardiovascular department. They opened up this new role to be responsible for the QMS from the manufacturing plant where the candidate will be closely working with.
ROLE DESCRIPTION
You will coordinate quality measurements and improvement of the Quality Management System of the Medical Plant. This means you will set up and be responsible for the Quality System in the organisation and lead improvement projects to ensure that all quality processes are performed in accordance with the defined requirements. Here you will coordinate, coach and train teams to ensure these requirements and be visible within the plant as the responsible person.
RESPONSIBILITIES
- Setting up the QMS of the production plant
- Train, coach and coordinate projects to improve quality in the organisation
- Lead Improvement projects
- Perform internal and external audits
- Guidance and documentation of CAPA's
- Support Change Control Projects
- Support Regulatory Affairs team in accordance to quality queries
REQUIREMENTS
- Minimum of 3 years experience in QA or QS
- Experience in Medical and/or Pharma field
- Knowledge of Quality standards such as ISO 9001, ISO 13485 or FDA 21 CFR 820
- Audit experience is an advantage
- You have a practical above a theoretical approach
- Be able to communicate on different levels
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.
