OBJECTIVE:

• To obtain a position in an energetic and growing company that is committed to customer satisfaction as a means of residual business.

SUMMARY:

• Comprehensive, quality, engineering. machining, metal fabrication, stamping, welding and injected/thermoformed plastics experience in medical device, aerospace and automotive operations, including ISO/FDA compliant Quality Systems, Capitol Products, Customer Service, Post Market Surveillance, R&D, product design & development, quotation, Gage R&R/Metrology, prototype modeling, 3D modeling, NC and CNC programming, CAD/CAM and CMM. Purchase of machinery, raw materials and tooling. Extensive front line experience in solving customer design and tooling issues. Computer literate in Pro/E (10 years), AutoCAD (14 years), Solid Works (1 year) and have taken the Introduction to Unigraphics Course.

PROFESSIONAL EXPERIENCE:

Confidential, Warsaw Indiana

CAPA - SCAR Investigation/Remediation Team Lead

Responsibilities:

• CAPA-SCAR Remediation for legacy documentation in response to an FDA Audit and subsequent 483 Actions.
• Complaint Handling-Product Surveillance Activities to address preventative and corrective actions.
• Independent reviewer of team deliverables prior to submittal for final approval.
• CAPA Blitz team member designated to facilitate CAPA Owners to expedite newly opened CAPA’s to closure

Confidential, Vandalia Ohio

Sr. Quality Engineer

Responsibilities:

• Responsible for all quality engineering activities for Orthopedic Implant manufacturing 1st tier vendor business unit
• Process Validation IQ,OQ, PQ Generation and Execution
• MSA, Gage R&R, DOE, PFMEA and Quality Control Plans
• Inspection Protocols
• CAPA-SCAR remediation
• Complaint Handling-Product Surveillance Activities
• Vendor Quality Management

Confidential, Jeffersonville Indiana

Sr. Mfg. Quality Engineer

Responsibilities:

• Responsible for all quality engineering activities for Urology/Women’s Health manufacturing business unit.
• CAPA-SCAR remediation
• Complaint Handling-Product Surveillance Activities
• Vendor Quality Management

Confidential, Warsaw, IN

Quality Assurance/Regulatory Compliance Remediation Consultant

Responsibilities:

• Global Packaging Design/Development and Design Controls.
• Responsible for the design, testing, and implementation of instrument tray, case and container systems for all company product lines. This position interfaces extensively with Product Development, Regulatory Affairs, Marketing, Quality Assurance, Strategic Sourcing, outside vendors and developing surgeons.
• Creation of Design Verification Technical Protocols for sterile barrier packaging systems
• Packaging, Process and Test Method Validation, IQ, OQ, PQ, PPQ Protocol Creation and Execution.
• Remediation activities associated with sterile container seal tensile/strength integrity.
• Packaging, Process and Test Method Validation, IQ, OQ, PQ, PPQ Protocol Creation and Execution.

Confidential, Dover, OH

Responsibilities:

• Validation, Re-Validation Remediation activities
• Packaging, Process and Test Method Validation, IQ, OQ, PQ, PPQ Protocol Creation and Execution.
• Resolution of existing CAPA and Non-Conforming Material Report issues
• Creation and Implementation of new Product Labeling/ Product Segregation Procedure and supporting SOP’s.

Confidential, Warsaw, IN

Responsibilities:

• Drafting and submittal of a complete Validation Master Plan for the Warsaw Pilot Plant Expansion that will be used as a template corporation wide after implementation in the pilot expansion.
• Supporting Documents (Validation Plans, Risk Assessment, System Specifications, Validations (IQ/O0Q/PQ), Product Component Requirement (Product Spec.), Traceability Matrix, Process Parameter Specification, Sub-Process Flow Chart, Test Method Validation Protocol, Master Validation Summary Report)

Confidential

Responsibilities:

• Remediation activities related to: Site specific Quality Plan, Validation/Re-Validation, Test Method Validation and IQ, OQ, PQ, PPQ Protocols.

Confidential, Fort Wayne, IN

General Manager

Responsibilities:

• Transitioned the company from a custom machine and tool building business into a Medical Device Contract Manufacturer.
• Daily operational/economic control of the company with a focus on building the Sales/Marketing force for the FDA regulated Medical Device Industry.
• Author, Implemented and Trained ISO/FDA Quality System Company wide and provide ongoing support
• Restructured management responsibilities globally to conform to FDA 21 CFR 820 and ISO 13485:2003
• Trained entire Sales/Manufacturing staff on the nuances of the Orthopedic Implant/Instrument business.

Confidential, Columbia City, IN

Quality and Process Engineering Manager

Responsibilities:

• From a bare construction site to Baseline Year, Site Specific FDA Notified Body Audit performed by BSI, resulting in ISO 13485:2003 . This involved supervising construction of thefacility, purchasing the manufacturing equipment, and hiring the staff, all concurrent with authoring, implementing and relevant systemic controls for operations, engineering and quality systems. This entire activity was accomplishedin 9 months.

Confidential, Churubusco, IN

Responsibilities:

• Introduce FDA compliant regulations into existing ISO system. Implement, train and dovetail systems in effected business units.
• Development of Regulations, Specifications, Procedures, Work Instructions, Process Control Plans and Modifications to Quality Manual.
• Creation of Key Control Characteristic Sheets for in-process and final inspection criteria.
• Development of Validation and Operational Protocols for Medical Device component processes.

Confidential, Kokomo, IN

Project Engineering Manager

Responsibilities:

• Project Management of all fabricated metal component sales for the Medical Device Industry.
• Customer interface for design review.
• Scheduling and generation of CNC programs for fabricated or machined metal components.
• Design and buy/build decisions for required tooling.
• Creation of Work Instructions, Routers and Quality Criteria documentation.
• Acquisition and qualification of outsource vendors for plating, nylon powder coating and silkscreen artwork.

Confidential, Pierceton, IN

Manufacturing Engineering Manager

Responsibilities:

• Introduced ISO 13485 regulations for metal-fabrication/machining into existing system. Implement, train and dovetail systems in effected business units.
• Project Management and scheduling of all projects progressing thru the Manuf. Eng. Group.
• Manufacturability review of all concepted projects before customer approval. Final Design Review after customer requested changes and acceptance.
• Creation of Work Instructions, B.O.M’s, Routers and Quality Criteria documentation.
• Designed and buy/built decisions for required tooling.
• Generation of CNC programs for fabricated, machined metal, thermoformed polymer and plastic components.
• Generation of laser artwork programs and silkscreen artwork templates.
• Production of proto-types, functional and first article samples for customer approval.
• Direction of Formal hand off meeting to Production Manufacturing Group after customer approval of First Article.

Confidential, Fort Wayne, IN

Modeling Engineering Manager

Responsibilities:

• Design review and production of first article quality prototypes of CNC machined metal and polymer components for the Tactical Communications Unit.
• Design review and production of CNC fabricated or machined metal components for the Aerospace/Satellite Unit.
• Liaison between Design and Manufacturing Engineering Groups to address producibility issues and prepare for Production Launch.
• Generation of CNC programs for metal fabrication, machining and tooling.
• Represented the Model Engineering Group on the ISO 9000 Steering Committee Team that prepared the Fort Wayne facilities for .

Confidential, Fort Wayne, IN

Production Supervisor

Responsibilities:

• Supervision and scheduling of manual and CNC fabrication area.
• Design and buy/build decisions for production fabrication and stamping tooling.