Experience

Neuroelectrics

• Spain
• Medical Device
• 1 - 100 Employee

• Production Specialist

  • Sep 2021 - Present

  - Manufacturing documentation: update SOPs, registry, and storage of QMS registries including calibrations, equipment maintenance, manufacturing QCs, area control registries, NC registries, and CAPA execution. Being the author of more than 30 SOP, and completing and managing the follow-up of more than 10 CAPAs. - Quality control: from the definition of QC tests during the process design of manufacturing activities to the execution of quality controls. - Preparation and follow-up of regulatory audits including ISO13485 and MDSAP audits. - Batch approval: completing the approval and release of batches, including the revision of the documentation, labels, and records to ensure compliance with the regulatory requirements. Providing supervision for more than 300 batches released and giving approval to more than 100 of those batches. - Production Validations: IQ OQ and PQ of the production manufacturing processes, including the validation of SMT process for the manufacturing of high precision PCBs. - Manage production: planning the manufacturing and shipment orders and coordinating the team to ensure that products are delivered to the customer on time. - Other tasks and support to other departments including creating the documentation for the shipping of dangerous goods to multiple regions (including the following regions USA, China, UK, France, Germany, and Australia); participating as a project manager in the migration of the company`s ERP; revision of risks analysis for Medical Device products; revision, analysis and accountability of manufacturing costs; gathering and creating the documentation necessary for the renewal of the Medical Device license. Show less



Dara Pharmaceutical Equipment

• Spain
• Machinery Manufacturing
• 200 - 300 Employee

• Documentation Technician

  • Mar 2019 - Jul 2019

  - Participating in the revision of SOPs. - QC execution. -Revision of documentation and manufacturing records and documentation. - Participating in the revision of SOPs. - QC execution. -Revision of documentation and manufacturing records and documentation.