Jorge Torres Email & Phone Number

Irvine, California, US

• Provide ongoing consulting services to clients in Medical Devices and In Vitro Diagnostics in the development and management of their Quality Management Systems (QMS) to ensure alignment to the latest standards and.
• Interim site quality leader responsible for the development of a Quality Management System aligned with FDA Emergency Use Authorization (EUA) and ISO 13485 for an In-Vitro Device manufacturer of Molecular Assays for.
• Development and ongoing Management of a Quality Management System aligned with ISO 9001 for an importer and distributor of drug infusion pumps.
• Manage Document Control, Training, and CAPA systems for an ISO 13485 certified medical device manufacturer of a wearable medical device for tracking of vitals like temperature, oxygen saturation, and blood pressure..
• Implementation of Greenlight Guru electronic Quality Management System (eQMS) for multiple clients.
• Quality Systems Development, and Management for a leading calibration gas and specialty gas manufacturer. Implementation of a micro GMP/QMS to meet class 1 exempt calibration gas requirements.

Randolph, NJ, US

Alpharetta, Georgia, US

• Avanos Medical, formerly Halyard Health / Kimberly Clark / I-FlowPlan, direct and conduct activities that ensure quality systems remain in compliance to evolving regulatory requirements and in support of production of.
• Led the EU MDR gap assessment for QMS and directed remediation activities (2019).
• Developed interactive MDSAP training tool and deployed it to global sites (2018).
• Implemented ISO13485:2016 to all sites by leading gap assessment and remediation activities (2017).
• Hosted first Avanos (Halyard) MDSAP Notified Body audit (2016) with zero (0) major nonconformities and developed gap assessment and training program for all manufacturing sites. Actively led or supported subsequent.
• Developed the Learning Management System (LMS) strategy for the entire organization using ComplianceWire (2015) and Success Factors (2018).

Alpharetta, Georgia, US

Halyard Health, formerly Kimberly-Clark. Halyard Health was subsequently re-branded as Avanos Medical.Refer to Description for Avanos Medical.

US

I-Flow Corporation, a Kimberly-Clark company. I-Flow and Kimberly-Clark Healthcare was subsequently spun off as Halyard Health and later re-branded as Avanos Medical.Refer to Description for Avanos Medical.

Irvine, CA, US

Provide leadership in the implementation, maintenance, and improvement of companywide quality management systems and support processes. Monitor the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards.Manage the company’s document control / product.

Kennesaw, Georgia, US

• Management Representative responsible for implementing, updating, and maintaining the quality systems to support manufacturing operations and ensure compliance with current FDA and European Medical Device Directive..
• Assessed the Quality Management System (QMS) and led updates to support operating objectives while improving compliance. Significant updates included:o Rewriting the Design Controls and Risk Management procedures to.
• Hosted FDA during QSIT inspection which resulted in no observations. Hosted FDA Laser Products inspection. Supported FDA BIMO audits.
• Hosted all notified body (BSi) surveillance and recertification audits in support of CE Mark and Canadian license. Prepared and submitted all audit responses; responsible for assuring completion of all audit corrective.
• Attained ISO 13485 lead auditor certification and led all supplier qualifications and supplier audits to ensure suppliers meet regulations and internal requirements.
• Prepared and submitted annual regulatory reports such as FDA annual PMA report and Canadian licensing registration.

Abbott Park, Illinois, US

• Work with cross-functional teams performing gap analyses of quality systems and determining requirements for compliance with drug and device regulations. Implement required system enhancements and support.
• Project Lead for Change Management System. Successfully implemented and provided support and guidance to users of Change Control process. Developed and conducted change management training.
• Prepared audit questionnaire based on FDA regulations, ISO standards, and MedCert guidance to be utilized during mock audits. Conducted mock audits and area walkthroughs to ensure compliance with regulations and.
• Developed and conducted audit conduct training to supervisors and subject matter experts.
• Designed Quality System Regulations and Good Manufacturing Practices training for the organization; provided train-the-trainer classes and presented training to the organization.

Bethlehem, PA, US

• Management of Product Complaints and CAPA departments. Perform Failure Investigations and Root Cause Analysis for in-house manufacturing issues and product complaints. Provide review and approval of product.
• Reduced backlog of Product Complaints from 167 in June 2004 to less than 40 in June 2005.
• Contributed to a successful FDA PAI/GMP inspection in October 2004 resulting in approval of a new drug product.
• Revamped CAPA and equipment / process validation program process and provided training and guidance to the organization.
• Conducted process and equipment validation of aseptic drug filling manufacturing equipment.

Irvine, CA, US

Define process validation requirements and develop test plans (IQ/OQ/PQ) for cardiovascular products. Provide quality engineering support of production lines; review and disposition non-conforming products and components (MRB). Review and update Device Master Record documentation as required per change control procedures. Define quality control inspection.

Deerfield, Illinois, US

Define process validation requirements and develop test plans (IQ/OQ/PQ) for cardiovascular products. Provide quality engineering support for the launch of a drug coated blood reservoir. Conduct equipment, process and software validations, Failure Mode & Effects Analysis (FMEA), Microbiological/ Biological/ Chemistry submissions, statistical analysis.