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 Schaffhausen Switzerland.
Specialist in custom-made quality control solutions for In Vitro Diagnostics. A broad variety of products sold and used in more than 80 countries.
ROLE DESCRIPTION
As the QA manager, both interim and permanent, you will be the operational manager of the Quality related items within the company. Activities you will be ensuring QMS compliance, initiating CAPA (root cause) and helping the R&D division in ensuring compliance to the regulations MDD, and preferably also on IVD and FDA regulations.
RESPONSIBILITIES
- Guaranteeing all the business processes in the Quality System
- Registration of Quality Documents
- Implementing new or revised regulations
- Execute, report and analyse of suppliers and performing internal audits
- Registration and analysis of complaints about deviations
- Motivating the employee about Quality and guiding them through the processes
- Contactperson for Quality within the company
REQUIREMENTS
- Education in Quality Manager, with a minimum of applied sciences (HBO)
- Extensive knowledge of ISO 13485, ISO 14971, GMP and FDA regulations
- Extensive knowledge about internal auditing
- Flawless English and German (oral/written)
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.
