MicroPort Scientific Corporation is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-
quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-
wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Endovascular, Neurovascular, Electrophysiology, Surgical Management, Diabetes Care and Endocrinal Management, and others.
MicroPort is committed to its vision of being a patient oriented global enterprise, improving and reshaping patient lives through application of innovative science and technology.
MicroPort CRM develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures.
Saluggia, Italy; and Santo Domingo, Dominican Republic.
Quality Systems Leader (M / F)
The Quality Systems leader is primarily responsible for supporting QA / RA solutions in place within the CRM organization from a Quality / Regulatory perspective and for ensuring validatation of changes of the processes managed by these QA / RA solutions.
Essential Functions :
The Quality Systems leader will support QA / RA solutions from a Quality & Regulatory perspective and will develop validation strategy when necessary, in accordance with quality / regulatory requirements.
He / She is responsible for building and maintaining expertise on the QA / RA portfolio for the Quality and Regulatory functions for CRM.
He / she supports other departments to ensure that QA / RA Tools are developped and maintained in accordance with the regulatory requirements and in collabration with IT department.
This includes the following activities :
Support and maintain QA / RA systems and processes in collaboration with IT :
Perform or aid in the analysis, requirements specification, design, and implementation of new / modified systems for the Quality & Regulatory functions :
Support and maintain the UDI process including interfaces with database (e.g. EUDAMED, GUDID)
Keep awareness of evolving regulatory requirements and technology developments for the specific business processes and influence the IT stakeholders and vendors in addressing these evolutions in the most efficient way.
Other duties as required.
Education and Experience
Knowledge and Skills