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Miguel Torres Resume; 03-17-2016
- 1. Page 1 of 3 MIGUEL TORRES Address: 4867 E. Gage Ave. Apt. #205 Bell, CA 90201 Cell phone: (562) 644-1303 E-mail address: migueltorres0507@att.net SUMMARY A Quality Compliance Specialist/Quality Engineer with 18 years of experience in the medical device industry. Skilled in CAPA Handling, Complaint Handling, Internal Audits, Document Control Change, Microbial Monitoring, and implementation of Quality Systems. Experienced with Process Validations, Risk Analysis, Supplier Evaluation, Quality Manufacturing Process Documentation, Inspection Activities, and NCMR’s. Knowledge of ISO 9001, ISO 13485, and QSR (CFR Part 820). A Certified Quality Auditor and Certified Biomedical Auditor by the American Society of Quality. MAJOR ACCOMPLISHMENTS Escorted two FDA inspection audits (2011 & 2014) providing requested objective evidence and demonstrating compliance to FDA regulation. There were no FDA form 483 issued. Developed successful marketing of the Avalon Elite Product supporting by releasing material specifications, working instructions, and related procedures for adequate transfer to manufacturing. Supported in the successful development of Maquet Peripheral Cannulae (OEM Customer) by working with the Advanced Research and Development team to release material specifications, working instructions, and related procedures for adequate transfer to manufacturing. Accomplished the transfer project for the Avalon Elite Product from Surge Medical Grand Rapids to Avalon Rancho Dominguez California, resulting in saving cost from the final packaging and sterilization process. PROFESSIONAL EXPERIENCE Avalon Laboratories, LLC (a Nordson Company) 10/2010–Present QUALITY COMPLIANCE SPECIALIST/QUALITY ENGINEER Manage the Internal Audit Program o Establish and publish annual schedule and ensure audits are conducted in accordance with the schedule. o Publish updates to schedule as needed. o Identify, train, and support internal auditors. o Conduct audits and publish audit reports and closures. o Review and approve corrective actions associated audit program. o Establish, monitor, and publish metrics associated with the audit program. Manage the Corrective/Preventive Action Program o Conduct failure investigations to determine root cause and appropriate corrective/preventive actions. o Ensure documentation associated with CAPA is adequate and completed in a timely manner. o Establish, monitor, and publish metrics associated with the CAPA program. o Coordinate activities and conduct meetings between US and Mexico facilities to ensure timely responses to corrective actions. Manage the Complaint System and Customer issued SCAR’s o Log customer complaints and reply with acknowledgment within 24 hours.
- 2. Page 2 of 3 o Maintain Customer complaint and SCAR log, files, and metrics. o Conduct investigations for complaints/SCARs and approve corrective actions associated with complaint/SCAR resolution. o Prepare customer communications summarizing investigational findings and actions taken. o Coordinate activities and conduct meetings between US and Mexico facilities to ensure timely responses to complaints/SCARs. o Respond to Customer with final investigation findings and actions taken. Manage the Supplier Management Program o Review documentation to approval or disapprove new suppliers. o Ensure audits are conducted in accordance with the Annual Supplier Audit Schedule o Conduct supplier audits and publish audit reports and closures. o Monitor supplier performance and publish supplier score cards as required. o Issue Supplier requests for Corrective actions (SCARs) and ensure that appropriate responses and closures are obtained in a timely manner. Manage the Environmental Monitoring for the US facility o Schedule suppliers who conduct the monitoring/certification and escort while onsite. o Review and publish the reports relative to monitoring and ISO 8 recertification. o Establish action limits yearly based on historical data. o Establish, monitor and publish metrics associated with monitoring program. Manage the Product Testing o Coordinate Bioburden and BET testing. o Review, summarize, and publish results of the testing. o Establish action limits yearly based on historical data. Provide Quality Expertise Support and Training o Conduct training for Quality System related procedures and compliance issues. o Provide support as subject matter expert for customer and regulatory audits of the Quality System. Provide Quality Engineering Assistance o Review and approve protocols and reports. o Review and approve Engineering Change Requests and Document Change Notices. o Asses non-conformance material reports and perform sterilization load release o Develop product certifications. Avalon Laboratories, LLC 12/1997 – 10/2010 ENGINEERING DOCUMENTATION TECHNICIAN/FINAL QC INSPECTOR Managed and Processed R&D Documentation o As part of the Advanced Product Development team, developed R&D work instructions to build experimental level prototypes. o Maintained computerized correlation summaries of BOM’s (Bill of Materials) and documents of related product parts and components for several projects during development phases. o Wrote protocols and reports and generated drawings for documentation purposes using AutoCAD and Corel. o Submitted to the Change Control Board DCN’s (Document Change Notice) for new material specifications, components, tooling, equipment, procedures, work instructions, and sub-assembly product drawings for appropriate release into the Document Control system. o Trained Production Employees in new processes and techniques. o Provided support to engineering to update existing production documentation in order to improve overall yields. Planned and Performed Final QC Inspections o Developed inspection plans and performed final inspections based on sampling size according to product specifications and drawings following indicated methods and using calibrated equipment. Initiated Non-Conformance Material Reports when products were out of specification.
- 3. Page 3 of 3 PROFESSIONAL STUDIES ASQ Certified Biomedical Auditor ASQ Certified Quality Auditor ASQ Certified Quality Technician East Los Angeles College Architectural Computer-Aided Design (2005-2007) SPECIAL TRAINING AND KNOWLEDGES Certified Six Sigma Green Belt (ASQ Refresher Course) Certified Quality Auditor – Biomedical (ASQ Refresher Course) Certified Biomedical Auditor – Biomedical (ASQ Refresher Course) OCRA CAPA Training Q-Plus Labs Calibration Training ISO 9001:2008 36-Hour Lead Auditor with Medical Device Focus (ISO 13485:2003) Training Spanish (Native Language) COMPUTER SKILLS AutoCAD 2007 Minitab Software Microsoft Office (Windows, Outlook, Word, Excel, etc.) MISys (ERP System) Corel Visio