SUMMARY I have a deep, yet diverse background in electrical engineering, software quality, product quality, change control, product lifecycle documentation, batch release, and SAP. Over my career I have served in the roles of engineer, software quality engineer, and quality management in the medical device industry. My background and experience enables me to bring a balance between electrical engineering, SAP, software engineering, and quality. In addition to these responsibilities, I have been responsible for quality engineering activities including process validations, incoming inspection, and risk management. I have a proven track record driving product and process continuous improvements across all parts of an organization as well as proven leadership to bring teams together to achieve breakthrough results. Specialties: -Medical Device -Quality Assurance -Change Control -Bill of Materials -DMR -Validation Master -Electrical Engineering -Software Validation -Complaints -Product Documentation -SAP: LIMS, QM, PDM, Solution Manager -Project Management -PDM -PLM -Incoming Inspection -Process Validation -Risk Management -FMEA -DHR -21 CRF 803, 806, 820 -ISO 13485 -Document Control -URS -UAT

Quality Manager @ Managed direct aspects associated with product quality assurance for Bayer Diabetes Care. Responsibilities include overseeing the compliance review of manufacturing batch records and product release, global product change control, deviations, validation documentation, as well as sample retention storage. -Oversee all product document control processes, including Device Master Records, Device History Records, change control, deviation, validation documentation, and technical reports. -Provides Senior Quality Leadership direction and member of the Quality Leadership Team for Diabetes Medical Care. -Performed Review Chair for all Global product change control including enforcing Item/BOM configuration management procedures; maintain BOMs and product structures for electronic and mechanical assemblies. -Responsible for DHR batch records department and identified discrepancies that require investigation prior to release. -Provides CAPA leadership and final review. Member of the CAPA Review Board. From February 2013 to Present (2 years 11 months) Supervisor, Product Documentation: Manager, Quality Engineering @ Managed change control activities including releasing engineering specifications, technical drawings, and software validation documentation using SAP ERP R/3 PDM change control software. Responsible for Quality Engineering activities including process validations, incoming inspection, and risk management. -Ensured lifecycle documentation is compliant to company policy and FDA regulations. -Performed software configuration user acceptance testing and validation documentation using HP Test Tool Quality Center. -Reviewed and approved software test plans, test cases, and test summary reports for accuracy. -Interfaced with key stakeholders in resolving technical/lifecycle documentation discrepancies to ensure timely release of product for production. -Engaged with business partners and other IT teams to formulate and structure technical solutions. -Enforce Item/BOM configuration management procedures; maintain BOMs and product structures for electronic and mechanical assemblies. -Maintained staffing by interviewing, hiring, training and providing staff development through performance evaluation and corrective counseling. -Managed incoming inspection processes to meet production timelines, optimize direct to stock programs and monitor supplier performance. -Developed and executed process validation protocols. -Identified process/product discrepancies that require investigation prior to release and assures appropriate segregation and documentation to support global quality and regulatory requirements. -Interfaced with circuit board contract manufacturer in releasing new products and resolving quality concerns. Also, facilitated vendor relocation and RA activities. -Oversee the non-conforming material process and facilitate MRB meetings/discussions to address and resolve non-conformances related to products and/or processes. Responsible for DHR batch records department and identified discrepancies that require investigation prior to release. From August 2009 to Present (6 years 5 months) Electrical Engineer Research Assistant @ Researched and developed various mechatronic engineering designs that combined mechanical, electrical engineering, and computer science for instrumentation and automatic control systems. -Performed bench level measurements of complex analog and digital circuits, data correlation analysis, and functional testing/debugging using electronic testing equipment. -Researched system integration of various analog and digital circuits, controllers, actuators, various motors, sensors, stepper motors, hydraulics, pneumatics, solenoids, relays, and electric motors using electronic testing equipment. -Programmed DPS / PIC embedded microcontroller with analog and digital signal processing, motor drive & control as well as graphical user interface development. -Developed process control system with programmable logic controllers (PLC) that interfaced with fluid systems, mechanical, and electrical devices. From July 2009 to August 2009 (2 months) Sr. Engineer @ Lead cross-functional teams in the investigation of post market quality improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible. -Interact with suppliers, manufacturing, engineering and other functional areas in resolving quality issues related to the development of new & existing products. -Represented department at various design reviews, and FMEA functions. -Prepared quality documentation and reports as required by ISO 13485, FDA QSR, and MDD regulatory standards. From January 2008 to June 2009 (1 year 6 months) Manager @ Managed Product Surveillance department, assigned workflow for technician and engineering staff to ensure timely completion of complaints. -Maintained staffing by interviewing, hiring, training and providing staff development through performance evaluation and corrective counseling. -Lead field-action discussion groups and resolution meetings. -Developed standard operating procedures and work instructions. -Lead global team in identifying system user requirements for software implementation. -Participated in developing operational qualification requirements and performing performance qualification testing documentation for software validation. From January 2005 to December 2008 (4 years) Specialist @ Performed failure mode analysis and batch document review. -Coordinated failure mode analysis. -Verified geometric dimensions. From March 2004 to January 2005 (11 months) Process Engineer II @ Utilized six sigma tools in driving continuous improvement throughput efficiencies. -Collected and analyzed SPC data to aid in problem resolutions and maintain quality control. -Lead Six Sigma teams in driving continuous improvement efficiency projects. From January 1987 to January 2004 (17 years 1 month) Electronic Technician @ Troubleshooting and diagnosing machinery with Allen-Bradley programmable logic controllers. -Troubleshoot and repaired electrical machinery with Allen-Bradley programmable logic controllers. -Diagnosed and repaired electronic circuit boards at component level. From 2001 to 2002 (1 year)

B.S., Electrical Engineering Technology @ Purdue University From 1995 to 2002 warsaw Sean Mills is skilled in: FMEA, Medical Devices, Quality Assurance, Process Validation, Product Launch, Change Control, Risk Management, Electrical Engineering, SAP, Technical Documentation, Software Validation, PDM, Quality Systems, Six Sigma, Manufacturing