

Engineering background with more than 20 years of experience in quality systems management (ISO9001, ISO13485), supplier qualification, managing audits and collaborating with cross-functional teams to ensure adherence to international standards. Familiar with standards (IATF 16949, ISO27001, ISO19011, ISO9102 and AQAP2110) and methodologies (FMEA, 8D, PCDA, W5, SPC, MSA). Ability to work in multicultural environments, adaptive decision maker, proactive approach, results orientation, flexibility, critical thinking and mediation attitude.
I implemented the QMS for medical devices, achieving the ISO13485:2016 certification and appointment as Quality Manager for the medical scheme.
I am responsible for all necessary activities related to the company certifications (third and second parts audits); follows up the Non-Conformity since closure out.
Lead and support supplier quality improvement initiatives using industry best practices.
I collaborate with Quality Head of the Group to establish quality goals, perform risk analysis and defining and monitoring the Company KPI.
I support the company in case of “non-standard” product to develop tailored processes to satisfy customer requests.
I draft and deploy system and process documentations.
I ensure the correct management of calibration and traceability of instruments (MSA).
I support the suppliers process selection defining quality standards and criteria.
Build and maintain strong partnerships with suppliers, to drive alignment and performance.
I lead quality audit on field ensuring excellence in installation service and process compliance.
I am POC (Point of Contact) into the organization in case of complaints as well as supporting field data analysis and providing valuable feedback towards the customer as well as inside the organization. I Ensure customer claims are properly managed.
Conduct and support in Root Cause Analysis (RCA).