Toni Ann Cruz
9750 West 59th Ave, Arvada. CO 80004
Building 2 Apt 103
720-903-5018
tonicruz49@yahoo.com

Quality Assurance / Engineering Professional
A dynamic professional with experience in an ISO 9001:2000/ISO 13485 quality systems and an engineering environment.  Recognized for following the code of ethics for auditors and requirements from the Registrar Accreditation Board (RAB) and ANAB.  Talented in preparing procedures, policies, flow charts, and other written materials to document corporate work practices.  Demonstrate strong understanding of the ISO Standards 10011 and 9001:2000.  Extensive experience with internal and external audits in aerospace and medical device companies.  Skilled at comprehending and summarizing concepts associated with complex technical processes.
Core Competencies
·	Project Management
·	Quality Assurance Engineering
·	Training & Development	·	Quality System Management
·	Business Processes
·	Operational Engineering	·	Leadership
·	Auditing Procedures
·	Technical Support 	
Professional Experience

ConMed							December 2013- March 2014
Graphics Regulatory Affairs Coordinator
Provided administrative/ technical, regulatory/ quality, support/process for management of the Complaint department.  Assured that Regulatory Affairs / Quality Assurance reporting, records, and procedures were maintained.  Assisted in development of Regulatory and quality procedures, regulatory submissions, and adverse event Medical Device Reports.
Key Achievements:
Ø Developed and completed all requirements within the allotted timeline.

Vital Signs Inc. a GE Health Care Company Englewood, Colorado         April – October 2012                           
Change Control Specialist
Created, submitted and evaluated product changes in Agile and maintained dual maintenance in the JD Edwards system.  Produced Engineer Change Request (ECR) for the purpose to either authorize the design work needed to implement the design change in a product or identify other actions needed.  Facilitated weekly Engineering Change Control Board (ECCB) Meetings that controlled the work flow with the Engineer Change Request (ECR) a lined with the Agile process.  Worked closely with Engineering, Regulatory, Purchasing and the Manufacturing floor to complete the Engineering Change Request (ECR).
Key Achievements:
Ø Introduced and implemented Agile Software

Covidien-Boulder, CO.						           2011- 2012
Quality Analyst
Wrote complaint evaluation reports on the results of troubleshooting and repair of complaint units; performed trend analysis, identified complaint trends and communicated with internal and external customers.  

UNITED LAUNCH ALLIANCE – Englewood, CO	2007 - 2009
Quality Engineer Specialist III
Provided supplier quality technical support for the Delta Program. Assembled, tested, and launched Delta operations, procedures, requirements, practices, techniques, and principles. Analyzed hardware nonconformance and dispositions. Provided technical solutions to a wide range of problems. Reported supplier quality ratings and provided direct access to the Supplier ASAP and the Livelink folders. Trained suppliers and participated in customer meetings. Supported the Supplier Quality Rating Board.  Utilize the LiveLink system to manage documents and product structures and the transfer of this information to Sharepoint for company usage.  Check accuracy of document changes and conformity to documentation standards. Initiate, demote or promote, review, and approve documents and product structures associated with new product design and engineering change orders within the LiveLink system. Merged two quality programs (Lockheed Martin and Boeing) into to one Quality Program.
Key Achievements:
•	Served as the Project Manager for launch of Delta and Atlas ASAP non-conformance rating rollout.
Ø	Recognized for setting up and maintaining the Procurements Quality Web Page.
GEOEYE (formerly Space Imaging, LLC) – Thornton, CO	2004 - 2007
Quality System Analyst / Lead Auditor
Supported the Configuration Management process by coordinating daily Engineering Review Board (ERB) meetings and documenting and distributing minutes. Maintained the Discrepancy Reporting system (DR) database and generated reports. Administered the GeoEye Document Control Center. Editor and corporate trainer for the on-line Document Management System (QSOL). Edited revisions and all new quality system documents for format and basic requirements before loading documents on the DMS. 
Served as the Quality System Lead Auditor to schedule and perform audits of GeoEye’s internal departments, including classified programs. Collaborated with other internal auditors to perform a majority of audits. Coordinated with department managers regarding the corrective action responses from internal and external audits. Provided audit and corrective action information to the Quality System Manager for quality system metrics reporting. Assisted in third party audits of GeoEye by its customers and ISO Registrars. Maintained the Quality System department documentation and files. 
Key Achievements:
Ø	Recognized for thoroughly auditing and maintaining the internal quality system.  
Ø	Developed and implemented the Quality Management System in compliance with the ANSI-ASQ-ISO-9001 standard.

Education & Credentials
Associate in Applied Science, Business
Bauder College – Arlington, TX
Lead Assessor of Quality Systems, IRCA Certificate #06-A-197
Green Belt Certified
MRB Certified

Training & Software Experience
MEGA Quality System Software ~ Cisco Certified Sales Professional ~ Microsoft Tools Seminar ~ Negotiating to Yes Seminar ~ SPIN Sales Training ~ SharePoint Administrator ~ SAP ~ LiveLink Administrator ~ ASAP Agile Design Owner/Change Owner ~  Prophecy ~ Oracle~ Star Award Winner ~ KC Complaint Data Base ~ JD Edwards ~ Agile Complaint Tracking System (CTS) ~ 

Security Clearance
Secret – DoD and National Reconnaissance Office (NRO)