QA Manager
Location: BelgiumSIRE 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 Limburg Belgium.
Our client is an international and innovative provider of dental solutions. The company's leading position in dental implants and innovative solutions makes it a dynamic and interesting workplace.
ROLE DESCRIPTION
As QA Manager you will be part of a mixed team consisting of RA and QA experts and will take over responsibility for the Quality Assurance Management System. Furthermore you will be reporting directly to the global QA department and help the company to ensure ISO 13485 and 21 cfr 820 guidelines.
RESPONSIBILITIES
- Manage members in the QA team
- Process and software validation
- CAPAs, Complaint Handling,..
- Internal Auditing
- Contact person for audits through external organisations (FDA, notified bodies)
- Ensuring ISO 13485 and 21 cfr 820 standards
- Risk management
REQUIREMENTS
- 5 years experience in QA (Medical Devices)
- Very good knowledge of ISO 13485 and 21 cfr 820
- First people management experience
- Knowledge of root cause analysis, process & software validation risk management
- Auditing experience
- Fluent in English and Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Krems.
