IQNet ISO 9001 Lead Auditor

- TüV SÜD product service. EU Notified Body. TA and QMS auditor. - Osypka AG, Rheinfelden, DE. Validation Engineer. November 2020- Current. Responsible for the validations tasks of new products during the process development process including process development reports, flow diagrams, test methods validations, master validation plan, process validations (IQ/OQ/PQ), design verification planning and testing, risk management task (FMEAs creation). - Boston Scientific, Coyol, CR. Process Development Quality Assurance Engineer. July 2017 – August 2018. Provide Process/Quality Engineering support to the manufacturing of new product development teams, ensure delivery of the highest quality product to the customer. Task included material qualification and composition assessment, Process validation (IQ, OQ and PQs), test methods validations (Gage R&R), master validation reports (MVP/MVR) and support to products lunches. Development of PFMEA and support to DFMEAs documents. - Boston Scientific, Burlington, MA, USA. Supplier Quality Assurance Engineer (acquisition assignment). December 2016 – July 2017. QS Integration assignment for the Cosman Medical acquisition (Burlington, MA), lead the integration of the material controls section of the company’s quality system. Including the development and implementation of SOPs and work instructions for: Supplier planning and selection, material qualification (FAI) and acceptance activities, Procurement, Supplier feedback and change control. - Boston Scientific, Heredia, CR. Supplier Quality Assurance Engineer. April 2014 – December 2016. Responsible for sustaining supply chain quality assurance for Electrophysiology diagnostic, therapeutic catheters and guide wires for interventional cardiology and peripheral intervention. Use of material control and risk management tools to guarantee compliance and patient care. Responsibilities were: Test method validation (Gage R&R), Supplier audits and validation (AVL), supplier change impact assessment, Supplier corrective actions request, Material qualification (FAI), material composition assessment.