Andocor is a Belgian company active in the field of cardiovascular surgery and anesthesiology. At our site in Hoogstraten, we manufacture high-quality cardiac catheters and cannulae.
Our commitment to scientific research and our endeavor to excellence and quality have propelled Andocor to successfully market and sell our innovative line of cardiac catheters and cannulae worldwide. This success is a result of applying high standards of manufacturing methods, a highly-qualified scientists and production personnel and cooperating side by side with the specialists and doctors who are the ultimate judge of Andocor as their partner for better patients’ care.
- Degree in Pharmacy, Biological or Chemical sciences, Engineering or equivalent with a minimum of 4 years of work experience within the medical device industry in Quality and/or Regulatory.
- Strong communication, organizational skills, ability to multi-task, prioritize and meet deadlines
- Fluent in both English and Dutch. French is an added value.
- Experience with the implementation and maintenance of quality management systems
- Proficient understanding of ISO 13485, ISO 14971, Regulation (EU) 2017/745.
- Understand requirements for product cleanliness, contamination control, bioburden testing, and/or sterilization is considered a strong plus
- Experience with similar medical devices and/or sterile devices is considered a strong plus
- Experience as an internal auditor is considered as a strong plus
As Quality Specialist you will ensure that all related processes and procedures meet the requirements of applicable regulatory standards, the EU Medical device regulation 2017/745:
- Maintain and improve the assigned QMS processes.
- Take an active role in QMS related projects
- Support during external Notified Body audits and follow up on any audit findings
- Work collaboratively with other areas to effectively investigate and solve quality issues and define CAPAs
- Act as quality responsible to support and train manufacturing personnel and to support projects to develop of new products
- Support in the transition to MDR and maintain compliance, e.g. write technical and regulatory reports such as Periodic Safety Update Reports, Post Market Surveillance Plan and standard operating procedures
Wij bieden U
- North of Antwerp
Interested in this position? Then contact us via email: email@example.com