381 days ago on sire-search.com

Remediation Specialist

SIRE Life Sciences

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Remediation Specialist

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 Genf Switzerland.

The company is one of the global orthopaedic companies. Their products are being produced locally in Switzerland, but next to this, they also have several production sites abroad. Just recently, they have received a warning letter from the FDA, and now they are in the need for a strong remediation consultant who can help them out to solve the issues related to this warning letter.


In this role, you will be part of the on-site remediation. With your experience in remediations, you will lead by example and help the rest of the team to understand the issues and how to solve them.


- Make sure the QMS is updated according to the findings
- Root cause analysis
- Managing CAPAs
- Report any findings to the Quality Director
- Team Lead for the remediation team
- Training to both the team and other employees


- At least 7-10 years of Quality experience in the Medical Devices and Pharma industry
- BSc and/or MSc in Engineering or life sciences. If this is lacking, then equivalent working experience
- Strong knowledge in both ISO 13485 and FDA 21 CFR part 820
- Fluent in English. Fluency in German is a strong advantage for your candidacy.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.