NICHOLE HUNTER VERNON

***** ****** ******* ***.  Moreno Valley, CA 92555 951-***-**** Home  909-***-**** Cell  wu3hmb@r.postjobfree.com

Having had over seventeen years of experience in engineering, quality, and manufacturing, I am confident that I could meet the needs of your company. My experience with ISO 9001, GMP, AIB, UL, CE, HACCP, and FDA standards would enable me to be an asset to your company. Experience includes the following:

Engineering Technician Associate Design Engineer

Project Engineering CAD - Solid Works, AutoCAD

Food Manufacturing

Product Documentation Management Quality Control Inspector

Injection Molding

Medical Device Manufacturing

Quality Control Analyst ISO 9001 Internal Auditor

GMP Internal Auditor

PROFESSIONAL EXPERIENCE

Engineering Technician - Ziehm Imaging Inc. 2007 to 2009

 Design engineering for a digital imagining medical device manufacture.

 Responsibilities included product designs for new configurations using Solidworks, validating hardware, software and product implementation.

 Planned and coordinated preparation of project documentation such as engineering drawings, production specifications and contract modifications to ensure customer contract requirements were met. This also included the review of military requirements for product integration.

 Prepared and directed preparation of product and system layouts, detailed drawings and schematics. Documentation included Work Instruction (WI’s) including Bills of Materials (BOM’s), Engineering Change Orders (ECO’s), product design and quality requirements. Maintained and updating support documentation including Standard Operating Procedures (SOP's).

 Conferred with engineers, managers, vendors and customers to discuss project requirements. Sourced and validated components for new product integration.

 Analyzed data to determine feasibility of product proposals. Installed electrical assemblies and hardware in housings, using hand tools and soldering equipment.

 Set up and conducted tests of complete units under operational conditions to investigate design proposals for improving equipment performance. Implemented new design applications and validations for military product integration.

 Experienced with leading projects requiring compliance with FDA, GMP/QSR and ISO 9001 design controls.

 Program planning and design controls which included risk management and control of quality documents.

 Performed first article inspections to ensure compliance to quality and regulatory standards. Team member of the Material Review Board for non-complaint components.

Quality Analyst Supervisor - Bericap North America 2006 to 2007

 Supervised quality auditors to ensure that food grade product quality standards and policies were being followed.

 Perform statistical analysis of processes and products to determine process capabilities and potentials.

 Responsibilities included new product qualifications and product implementation. Analyze and audit procedures and instructions for compliance with ISO 9001.

 Conducted ISO 9001, ISO 14001, GMP, AIB, FDA, and HACCP audits. Duties also included air quality, pest control, and microbial testing.

 Work with customers to resolve complaints and MRB product issue. Proficient in using the CMM.

Quality Control Inspector - Guidant Corporation 2004 to 2005

 Provide quality support for cardiovascular medical device manufacturing company.

 Helped to ensure delivery of the highest quality products to meet the need of our customers.

 Responsibilities also included making sure product is being produced in compliance to a FDA regulated quality system.

Project Engineer - Bioconnect Inc. 2001 to 2003

 Product design and validations for medical cable manufacturing company. Interfaced with OEM customers for implementation of new products.

 Designed injection molded tooling to meet the needs of customers and new products.

 Wrote operating procedures: MOP’s, SOP’s QOP’s. Close team involvement with manufacturing, quality assurance, purchasing, departments required daily for new product development, documentation, and implementation.

 Responsibilities also included regulatory compliance for FDA, GMP, and CE requirements.

 Efficient in, Ms Office, PowerPoint, Ms Project and AutoCAD 2000.

Product Documentation Manager - International EZ-Up 1999 to 2001

 Responsible for the implementation of new products from design to production.

 Developed production quality plan documents and systems in conjunction with other development team members.

 Re-configured part numbers system to an intelligent system. The implementation of this system increased the utilization of the MRP system and enhanced the knowledge of the products used company wide.

 I also preformed the duties of an interim Quality Control Manager.

Project Engineer - Stackhouse Inc. 1994 to 1997

 Product design and validations for medical/surgical manufacturing company.

 Close team involvement with manufacturing, quality assurance and purchasing departments required daily for new product development, documentation, and implementation.

 I used project planning to achieve milestone objectives on time and within budget.

 Responsibilities also included regulatory compliance for FDA, GMP, TUV, CE, and UL requirements. Obtained TUV GS, CE Mark for complete product lines.

Associate Design Engineer - Deutsch Engineered Connectors Devices 1993 to 1994

 I designed electrical connectors and contacts for medical, marine, and commercial use.

 Efficient in Hewlett Packard Design Computer Systems and AutoCAD Release 13.

Design Engineer / CAD Operator - Robertshaw Controls Company 1987 to 1992

 Applied Mechanical Engineering principles to design various controls using CAD/CAM technology on Intergraph Computer Systems.

 Also worked as an Electro-Mechanical Engineering Technician.

Laboratory Technician - Purex Corporation 1980 to 1984

 Worked in a research and development group, developing new products for consumer use.

 As a technician working with a project leader, I was responsible for performing various chemical and physical tests.

EDUCATION & TRAINING:

California State University, Long Beach

Mechanical Engineering - Pending

Risk Analysis

Solid Works Training

ISO 9001 Internal Auditor

GMP Internal Auditor

ACHIEVEMENTS:

Registered Patent for chemical formulation

Recipient of Customer Service Award.

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