For our client, a small enterprise developing, producing & selling a specialized Medical Device in the field of Cardiology, in order to reinforce its fast-growing team and its Regulatory Affairs/Quality Assurance department, we are looking for a Quality Assurance and Regulatory Affairs Engineer. The position would be based in the Canton of Vaud (CH).
Among other responsibilities you have to ensure that the Medical Device product meets all necessary requirements before they reach the consumer.
Your main responsibilities are:
- Monitor all activities within the quality assurance field
- Prepare Regulatory procedures according to the Medical devices directives
- Support and guide the company staff to comply with the norms, standards and regulations
- Maintain the QMS system according to ISO 13485 and QSR-FDA
Competencies and requirements for this position:
- BSc/MSc in relevant fields (Biomedical Engineering, Electrical/Electronic, Automatism/mechanical Engineering, Medical Devices etc.);
- Experience in the Quality Assurance in the medical device environment
- Profound knowledge of ISO 13485/9001 requirements
- In depth understanding of material quality control procedures
- Fluent English language skills, all other languages are an asset
- Excellent numerical skills and understanding of data analysis/statistical methods
- Good communication skills, great attention to detail and a results driven approach
If you are open for new possibilities and would like to work within a new fast evolving environment, please feel free to contact me
Tel: +41 (0)44 588 2611
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.