Ruben Rodriguez

Experience

• 

  Valeo

  Jan 1997 - Nov 2000

  GM customer complaint eng
• 

  CR Bard

  Sept 2007 - Jun 2018

  Supplier Quality Engineer

  Act as a quality liaison with suppliers and ensure quality support to all functional processes needed from the point of order through delivery. Monitor and conduct auditing function to assure compliance to systems and procedures. Perform and report supplier quality audits and help identify areas of needed improvement. Monitor corrective actions and report deficiencies in responses and results. Provide development opportunities guidance, training and assistance to incoming quality personnel. Facilitate and support audits by external agencies. Assist on transfer/validations activities for new projects and line additions. Assist on component / vendor qualifications. Ensure devices and supplier complies with FDA requirements. Develop, review and approve Product Validation Protocols. Develop and execute Supplier Audit per FDA Regulations, ISO 13485 and ISO 9000 requirements. Issue Audit Reports and follow up AAP process. Review and Approve Supplier Corrective Actions for all issues related to Delivery and Quality from suppliers. Proper follow up from suppliers (Mexican, US, Europe and Asia). Assistant to obtain credit and/or rework costs. Responsible for supplier related issues. Field returns analysis as well as developing implementation and follow up on corrective actions, internal corrective action development, implementation and follow up, Show less

• 

  Haemotronic S.p.A

  Jun 2018 - Apr 2019

  Validation Engineer

  Introducing and implement transfer design process to execute molded / extruded validations, included sealing process, labeling process, performs of functional test methods and sample size criteria. QMS mapping to identify all elements per ISO-13485-2016, update all level documentation (SOP, Forms, Work Instructions, and Process Control Sheets) to comply with GMPs and FDA regulations to extent scope for BSI certification. Train and certify Internal Auditor roster.

• 

  Ethicon, Inc.

  Jul 2019 - now

  Senior QA engineer supports energy products for laparoscopic and open surgery; such as HARMONIC® family ultrasonic devices offer precision, multi-functionality and strong vessel sealing. Validation support on DePuy Synthes transfer site product families Suture family validation (Gut & Silk),

  • Senior Validation Quality Engineer

    Oct 2019 - now

  • Validation Engineer II

    Jul 2019 - Oct 2019