Data Management/Change Management Specialist
Resume:
Summary
I'm a highly motivated detail oriented individual who has a strong integrity for quality. I have a creative mind for coordinating, analyzing and problem solving. I'm very efficient in high volume Change Orders (Manual/Electronic), Bill of Materials, Document Management and ERP systems under Quality and MFG Engineering. Achievement’s in Change Orders and Bill of Materials, coordinating and maintaining records for Device History, Device Master and DHF.
I’m well diverse in collaborating with functional team members in Quality, Regulatory, R&D, MFG Engineering, Purchasing, Production and Marketing.
Achievements:
Processed Change Orders (Manual/Electronic):
Performed and analyzed high volume Change Orders for Policy and Procedures, Design Drawings, Bill of Materials, Product Labeling and Product Configuration of high demand deadlines.
Assisted project teams in problem solving and recommendations for the ERP and Document Change Order processes to stream line the workflow.
Analyzed DRW’s, Department Procedures and Product Configuration:
Achieved problem solving with Design Drawing BOM’s and communicated the necessary recommendations to the functional teams.
Team involvement in evaluating and recommending changes to Quality Procedures for Change Control, Deviations, NCR’s, DHR and DMR’s to be in compliance with current practices.
Developed and implemented a Product Configuration (DMR) Database and in Windchill PDM system for a complete listing of the product DMR.
Developed and implemented DHR listing in excel and a PDF for end users and auditing purposes to eliminate master records from being miss handled.
Analyzed and Completed Product BOM Configurations. Example: Product that had over 300 components. Found and corrected discrepancies.
Quality Management Systems:
ERP systems (QAD, SAP, Agile) and Document Management systems (Windchill and EPDM).
Project team member to convert a manual change order system to electronic system.
Team member in creating and implementing a Change Order Process within an ERP and Document Management systems.
Other Areas of Achievements:
Assisted in team meetings to resolve Quality non-conformances NCR’s, RMA’s and Deviations.
Headed Project for the Company Divisional Separation of Product Drawings and configuration.
Team member in a 5S Lean Manufacturing for the manufacturing area to streamline workflow.
Team member to coordinated and conducted KPI Daily Management Board to resolve and find root causes of problem areas within manufacturing, sourcing and distribution of product.
Team member involvement for internal and external Quality, FDA, SGS Audits.
Work Experience at (IMRIS) Minnetonka, MN
March 2013 – May 2015
(CM/DM) Documentation Specialist
Analyzed and processed Change Orders for all functional areas.
Data entries in ERP system for BOM’s, Change Orders and new part numbers with data information.
Weekly reports to Quality Management on Change Order and Deviation Qty’s processed and pending open actions.
Collaborate with Quality, Regulatory, Purchasing R&D, MFG, Distribution, Customer Support and Marketing on change processes and non- conformances.
Analyzed, Coordinated and Maintained Product Configuration’s for Device Master Records, Device History Records and Device History Files.
Team member in FDA, SGS audits.
Run Production Product Labeling.
Attended weekly Quality Meetings.
Attended monthly Deviation and NCR meetings.
Work Experience at (St. Jude Medical) Plymouth, MN
Jan 2009 – Nov 2012
Group Lead Documentation Services
Group Leader for Quality Documentation Department and lead support for all functional areas.
Updated Documentation team of all procedure changes and ERP/PDM system changes.
Coordinated, Maintain and Implemented Change Orders, Product Configuration and Bills of Materials Quality Polices and Procedure Requirements.
Created and maintained Product Labeling.
(SME) Special Matter Expert in (Windchill) PDM System.
Project Team Lead for Division Product Separation.
Assistance for MFG Engineering Projects.
Work Experience at (St. Jude Medical) Minnetonka, MN
Jan 2002 – Nov 2009 St. Jude Medical, MN
Sr. Documentation Specialist
Maintain and Implemented Document Change Orders for Manufacturing Engineers.
Maintain and Implemented Bills of Materials in ERP system.
Maintain and Implemented Product Labeling.
Create/Maintain Department Policy and Procedures.
Assistance for MFG Engineering Projects.
Maintained Records Retention.
Project Team Member for Integrating from Manual PDM System to Electronic PDM System.
(SME) Special Matter Expert in (Windchill) PDM System.
Work Experience at (DAIG Corporation/St. Jude Medical) Minnetonka, MN
Jan 2000 – Jan 2002 DAIG Corporation/St. Jude Medical Minnetonka, MN
Documentation Specialist
Maintain and Implemented Document Change Orders for Manufacturing Engineers.
Maintain and Implemented Bills of Materials.
Maintain and Implemented Product Labeling.
Create/Maintain Department Policy and Procedures.
Work Experience at (DAIG Corporation) Minnetonka, MN
Jan 1992 – Jan 1999 DAIG Corporation Minnetonka, MN
Product Audit Specialist
Quality Inspection of Incoming and In Process Product and Materials.
First Article Inspections.
Calibration of Tooling.
In Process Auditing of the Manufacturing Operations.
Education/Training Certifications
Training Certifications:
Interleaf Quick Silver
Leadership for Leads
ASQ’s Certified Quality Auditors Program
Experience in Electronic Systems
Documentation System
Windchill
Agile
EPDM
ERP System
(SAP) - Systems, Applications and Products
(JDE) – JD Edwards
QAD
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