QA/RA Manager
Location: NetherlandsSIRE 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 Chemicals and Medical Devices organization, based in Noord-Holland Netherlands.
They are a company focused chemical healthcare and recovery products. Due to their growth and the current challenges they face in QA/RA they are now looking for an QA/RA specialist to take responsibility over these activities.
ROLE DESCRIPTION
You tasks will be to oversee, implement and improve all quality and regulatory activities. You will work within a small company as the expert in QA/RA and will cooperate with other responsible managers to increase company growth and improve further healthcare throughout Europe. Besides QA/RA your tasks will involve R&D and product development.
RESPONSIBILITIES
Your responsibilities and tasks will be but not limited to:
- Responsible for the QMS ISO 13485 and internal/external audits
- All regulatory affairs preparation, registration and maintenance of CE technical files, CE Design History and Device Master Records.
- Assuring that the company and supplying companies work according the set regulatory requirements
- Member of Design & Development team
- Performing PMS, CAPA and Complaint Handling
- Monitoring/Reporting relevant quality related issues
REQUIREMENTS
- A minimum of 6 years in medical devices/consumer health products
- QMS knowledge and working experience ISO 13485
- Proven experience both in medical devices QA and preferably as well RA
- Experience in chemistry and/or pharma background is a big plus
- Fluent in Dutch and English
- Must be capable of taking leadership and responsibility
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
