Quality Assurance 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 Switzerland.
This company is world renowned for their oncology treatment medical devices
In this position, you will be responsible for all supplier quality related issues. Next to this, you will be the senior quality professional within the team, reporting to the site QA manager. About ten percent of the job will require travelling, for example for taking part in audits.
- The candidate will be responsible for the consistent maintenance of the DMR and DHR.
- The candidate has to work together with the manufacturing department to make sure that the process of manufacturing is compliant.
- The candidate makes sure that per device the production process is documented to confirm the right level of quality is ensured in every production stage.
- The candidate checks that the process validation for the process of manufacturing is performed and maintained.
- The candidate will lead the audit programme for the suppliers of the client.
- The candidate also takes care of the new suppliers: evaluation, assessment and audit are all part of this.
- The candidate participates in the quality review board as QA representative.
- The candidate manages CAPAs for the quality of the suppliers and manufacturing.
- The candidate will directly report to the QA Manager and will be part of a team of 3.
- The candidate has to be fluent in German and in English and should have at least 5 years of experience in the QA field in the same type of functions.
- The candidate has to have knowledge of ISO 13485, 21CFR 820 and Council Directive 93/42/EEC.
- The candidate has to have degree in Engineering or Science and should have had training in Quality Management.
- The candidate has to be flexible to interact with the different departments within the company and should have good communication and people skills.
- The candidate should be able to work on his own, but should be open to discussions and solutions.
- The candidate should have good writing and conversation skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.