Senior Quality Assurance Manager
Location: SwitzerlandSIRE 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 Sankt Gallen Switzerland.
Our client is a professional Healthcare and Medical Devices organization, based in the German speaking part of Switzerland. They are specialized in Cardiovascular products and devices.
ROLE DESCRIPTION
The main activities for the quality assurance manager is to guide the R&D professionals through the Quality Regulations. The Amsterdam department is an early stage development site. You are the hands on Quality Assurance Manager. Coaching people around you is crucial in getting Quality around in the company, also aligning processes with America is crucial. It is possible to grow into the directors position on the long-term.
RESPONSIBILITIES
- You will be responsible for the engagement of the R&D professionals into the quality process.
- Engaging the R&D department in the Quality Mindset
- Responsible for maintaining the QMS
- Aligning the local QMS with the corporate QMS in the USA
- Training on Quality related R&D processes
REQUIREMENTS
- Knowledge of Design Control (FDA)
- CAPA knowledge
- Internal audit (lead auditor is a plus)
- 5-10 years of experience in Quality Assurance (plus; Medical Devices)
- Broad knowledge of ISO 13485 and FDA 820 CFR and MDD
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.
