Walter García Herrera

Independent evaluation of technical documentation of class IIa / IIb devices as per Council Directives 93/42/EEC (MDD) and Medical Device Regulation (EU) 2017/745 (MDR) for Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters and related tools (MDN 1203, MD 0101_1). CE mark process to access European union market.

EU Notified body tasks: - Perform QMS and Technology focused audits of medical device manufacturers according to: ISO 13485:2016, Council Directives 93/42/EEC (MDD), Medical Device Regulation (EU) 2017/745 (MDR) and Medical Device Single Audit Program (MDSAP) - Project handler for customers ensuring compliance as per conformity assessments based on Medical Device Regulation (EU) 2017/745 (MDR) requirements. - Project management of audits, technical meetings and technical documentation assessments

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.

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.

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.