SUMMARY

• Robust problem solving and analytical skills
• Proficient with working in a group and independently
• Resilient, efficient, methodical, and open minded when approaching a new problem
• Excellent interpersonal and communication skills.
• Six Sigma Green Belt
• Lean Quality Tools (FMEA, DfSS, Pareto Charts, Fishbone Diagrams, VSM, 5S, 8D methodology)
• Expert knowledge of Quality System (QS) Regulation/ Medical Device Good Manufacturing Practices
• Expert in Scrap Reduction & Output Increase
• Expert knowledge of design assurance
• Expert in Statistical Process Control (SPC)
• Experienced with Systems Design & Automation
• Expert knowledge of FDA Quality System Regulations
• Expert knowledge of: ISO 13485, ISO14000, ISO27001, ISO31000, ISO14971, ISO9001, ISO10993, ISO11137, ISO11193, ISO3864, ISO14644, ISO14698, ISO14708 international standards.
• Expert knowledge of Canadian Medical Devices Regulations (CMDR)
• Expert knowledge of blueprint reading and geometric dimensioning and tolerancing (GD&T)
• Working knowledge of multiple programming languages including: C++, MATLAB, Maple, HTML, CNC G - code, JAVA, Visual Basic, SAS, SQL, and more
• Able to TEMPeffectively translate and convey information
• Highly skilled in gathering evidence, analyzing data, and using LEAN tools to develop process improvement plans
• Trained in advanced Geometric Dimensioning and Tolerancing (GD&T) applicationsLandscape design and architecture
• Renovation activities revamping outdated living areas
• General maintenance of 24 apartment properties

PROFESSIONAL EXPERIENCE

Confidential, Warsaw, IN

Quality Engineer

Responsibilities:

• Liaison to manufacturing & gauge design engineers working to support daily production activities (Shoulder/Elbow /Hip/ Knee/ Ankle Products)
• Investigating, verifying, and completing disposition of nonconforming product reports
• Weekly and monthly process monitoring activities (OQ/PQ/PPQ/KPI process trending)
• Investigating and completing disposition report for gauges rejected for production use
• Heavily involved in gage design/development process
• Responsible for maintaining gage inventory and calibration cycle planning
• Responsible for training and mentoring colleagues new to the quality department
• Training and certifying operators to perform any role within the Hip, Shoulder, Elbow, Knee, & Ankle manufacturing cells
• Certification review board member (performance audits/ decertification/ recertification)
• CAPA task implementation, CAPA committee participant Extensive FDA audit activities
• Conducted random layered process internal audits of Extremities (ankles, shoulders, elbows) manufacturing cells
• Developed engineering tool used to determine if a gage requires a guard banded tolerance and if necessary by how much
• Feature Inspection Plans (FIP), Gage R&R, First Article Layouts (FAL), design/redesign gages, strategic planning, validation master plans, Health Hazard Evaluation (HHE), Quality Holds, Initiating and overseeing recall of productsComprehensive understanding of Design History File (DHF) and associated remediation activities
• Participant in FDA audit activities
• Demonstrated the ability to deliver, meet deadlines, and work in a results oriented manner
• Demonstrated expertise and ownership of work while working independently and considering options for completing assignments
• Demonstrated the ability to work within a multifunctional team environment and develop relationships outside of the department as well as outside the company (suppliers, contractors, regulatory agencies, etc.)
• Demonstrated the ability to communicate TEMPeffectively both orally and in written form across multiple levels of the organization
• Demonstrated expertise and technical understanding of existing Zimmer products and a basic understanding of competitive products
• Demonstrated full working knowledge of all supporting department needs and capabilities

Confidential, Crown Point, IN

Quality Engineer

Responsibilities:

• Gained thorough understanding of the manufacturing and quality control process of both extruded and molded medical devices
• Assisted in the conversion of all process and quality technical documentation used to new corporate documentation system
• Responsible for CAPA activities and leading non-conformance analysis for ourselves, customers, and suppliers
• Utilized root cause skills, root cause analysis, FMEA, MSA, Gage R&R analysis daily
• Developed process validation master plans
• Validated equipment and manufacturing processes, including lead IQ/OQ/PQ/PPQ protocol development and involvement with process validation master planning
• Applied Six Sigma LEAN tools to direct process improvement activities, including planning and implemented Kaizen initiatives
• Developed/ monitored/improved/ validated current and future production processes as required
• Provided technical guidance and training in advanced statistical analysis techniques
• Created / edited process and quality regulatory control documents QAP, SOP, SUP using change control request (CCR) procedure
• Defined sampling plans using statistical rationales
• Responsible for generating & troubleshooting CNC programs for QC metrology equipment
• Participated in New Product Development Process and Design Reviews
• Involved in Design Control, Quality Planning, Hazard Analysis, Biocompatibility studies, sterilization studies, packaging/shelf life studies, and developing/leading multiple simultaneous projects.
• Communicated with suppliers and customers on a regular basis to assure quality and reliability throughout design transfer process.
• Developed, validated, documented and refined QA Testing and Inspection procedures.
• Selected and acquired equipment /tooling as required
• Understand all environmental policies and significant environmental impact of job activities in accordance with regulatory standards.
• Prepared customer and supplier REACH & RoHS documentation IPC 1752 class 6
• Prepared non-conformance & scrap-reduction trending analysis reports used for 2014 strategic planning
• Developed and implemented processes, procedures and instruction to sustain and improve the Quality Management System.
• Supported Top Management in the development and implementation of quality systems strategies and objectives.
• Identified and solved product and process problems
• Supported various operational / manufacturing groups and suppliers in resolving and preventing quality issues
• Performed quality engineering analysis and responses for corrective/preventive actions
• Worked with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and TEMPeffectiveness of the corrective/preventive actions taken for non-conformance
• Conducted audits and assessments of internal processes and suppliers manufacturing sitesResponsible for tutoring groups of 15-20 sophomore, junior, and senior level students in math and science topics covered on the ACT Exam.
• dis position was a great reminder of the fact dat there are many different ways of solving the same problem.

Confidential, South Bend, IN

Test Engineer

Responsibilities:

• Responsible for daily operations of the X-ray Computed Tomography (CT) laboratory located in the Honeywell South Bend materials testing center.
• Reverse engineering of parts dat were no longer available coz vendor was no longer in business.
• Trained and certified to operate ICP, Eddy Current, Conductivity, XRF, & XRD laboratory equipment in Honeywell South Bend MTC labs
• Partnered with the wheel and brake engineering team, as well as non-destructive testing (NDT) specialists to perform DOE regarding the use of CT equipment and software for the evaluation of multiple manufacturing processes.
• Responsible for writing validation protocols and master plans for operational processes for the CT equipment.
• Utilized Six Sigma LEAN tools to streamline processes and optimize time and efficiency.
• Commissioned laboratory equipment
• Developed statistical analysis method for predicting scrap trending using CT data acquired throughout DOE
• Completed technical writing of work instructions and validation specifications.
• Involved in super computer design and modification, computer network architecture, and hardware troubleshooting
• Management and storage of large volumes of digital data
• Development of database architecture & hardware troubleshooting
• Managed multiple abstract projects at one time
• Management and trained contractors
• Updated and maintained chemical inventory (8 labs) and reported data to multiple tiers throughout the company