Veeresh Puttaswamy
Angestellt, Senior Quality Engineer, BellaSeno GmbH
Leipzig, Deutschland
Über mich
Experienced Senior Quality Engineer with over 3+ years of expertise in ISO13485 / EU-MDR compliance and quality management. Specialized in group-wide QM systems, I've led risk assessments, improving quality performance, and executing projects resulting in enhanced sterilization and packaging methods. With a track record of ensuring quality implementation and managing audits, I've positively impacted processes, achieving efficient document management and supplier relationships. Dedicated to maintaining high QC standards, optimizing processes, and ensuring seamless supply chain management. Want to be a part of that change the world needs.
Werdegang
Berufserfahrung von Veeresh Puttaswamy
Bis heute 2 Jahre und 4 Monate, seit März 2022
Senior Quality Engineer
BellaSeno GmbH
- Quality management according to ISO 13485/EU-MDR in production, and clinical investigation. - Manage overall Risk Assessment process (product, process, infrastructure. - Ensuring quality and the correct implementation of processes and systems. - Preparation and monitoring of audits by Notified bodies, authorities, and customers. - Monitoring and implementation of regulatory requirements in cooperation with (labeling, MDR requirements for Class III implantable and custom-made devices)
11 Monate, Mai 2021 - März 2022
Quality Engineer
BellaSeno GmbH
- Organizing and maintaining training records, supplier management, also monitoring the validation process (Product, process, and software) - Monitor and maintain the effective implementation of CAPA and non-conformity. - QC, creating the batch records. Handle the Post-processing(Cleaning, packaging, and sterilization) -Supply chain management including the final release of the product and delivery to the customer - Execute microbiological monitoring of the cleanroom environment and personnel monitoring
Sprachen
Englisch
Muttersprache
Deutsch
Gut