Yvonne M. Nelson

ad410x@r.postjobfree.com

Maple Grove, Mn

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EXPERIENCE DEPTH

To obtain a career by using my experiences and knowledge to advance in a Quality position. QUALIFICATIONS

25+ years of Quality/Manufacturing experience working with Aerospace, Pharmaceuticals and Medical Device Companies ISO9001, ISO17025, ISO14971:2019, ISO13485:2016, 21 CFR Part 820,11,210,211,212. AS9100 Experienced with ISO documentation: Document Control, Audit Prep, first article, Receiving Inspection, NPD, Calibration, In-Process and Final inspection using Applications such as Solid works, Windchill, Excel, Microsoft, Teams, SAPGuiXML Version 10, Infor LN Web User Interface Version 10.24, DocuSign, Leads, Epicor, Adobe Acrobat and Share point, Visual Factory.

SPECIAL SKILLS

Demonstrated Project Leadership skills, technical aptitude for learning new tools and systems, ability to drive results, foster teamwork, handle pressure, and supply feedback also Mastered reading and writing Laos language, Detail orientated, Organized, Analytical, Determined, Initiative-taking and Goal orientated. EDUCATION

North Hennepin Technical College/Paralegal

Empire School of Cosmetology

Scot Lewis Cosmetology School

PROFESSIONAL HISTORY

Nilfisk/Actalent Services August 14, 2023, to Current Data Migration Specialist SAP

● Analyze current data to ensure information accuracy, make updates as needed to the ERP system.

● Process Flow Analysis.

● Mapping the current LN-based processes, system functionalities and master data against Global template to identify the gaps that need to close to implement the Global solution.

● Collaborate with project teams to gather information for SAP Implementation.

● Collaborate with project teams to gather information for Backflushing Implementation.

● Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

TE Connectivity Creganna Medical / Oxford Global Resources May 18, 2020, to May 30, 2022 Quality Analyst / Technical Writer

● Leadership roles in completion of the SAP tasks and product documents. Lead Team to create new forms and update MPI based on Legacy LHR’s to coincide with the Implementation of SAP Systems.

● Researched, Writes, creates, and edits Manufacturing Process to support implementation of SAP Systems.

● Collaborate with project teams to gather information for SAP Implementation.

● Work with Quality Engineering and Manufacturing Engineering peers to follow internal processes and procedures.

● Provide Support and direction for the implementation of SAP associated with New Product Development projects for the Research, Development and introduction of new Products, Processes and Technologies.

● Writes, edits, reviews, and formats documents that conform to internal document standards, while meeting project timelines.

● Coordinates content development with multi-discipline subject matter experts. Page 2 of 3

● Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

Takeda Pharmaceutical Co. / Kelly Services Sep 20, 2019, to Mar 31, 2020 Document Coordinator II

● Assemble controlled GMP documentation for use including logbooks and controlled procedure document binders throughout the facility.

● Review documentation given to Document Control for archiving for good documentation practices requirements.

● Process archive documentation by updating logbooks and spreadsheets to keep controlled documentation archive storage.

● Archive received documentation in Document Control Archive according to archive procedure including placing in proper storage location and method of storage.

● Supply audit support for external/internal audits by fulfilling audit documentation requests.

● Maintain index of Document Control Archive room, including inventory for documentation that is present on-site and documentation that is located off-site.

● Supply customer support to other departments on Document Control related procedures or documentation requests from the archive room.

● Perform internal documentation audits to fulfil annual requirements including controlled hardcopy binders, global signature, and laboratory notebook.

● Develop and support processes for electronic document storage system.

● Perform periodic reconciliation on issued documentation including logbooks and laboratory notebooks to assure prompt return.

Boston Scientific Corporate/ Entegee Mar 5, 2019, to Nov 3, 2019 Quality Engineering Technician II

● Perform project and product testing.

● Perform basic statistical analysis and communicate results to teams.

● Contribute support for CAPA activities.

● Show areas of improvement and take part in continuous improvement projects.

● Perform testing, gather, and record data, analyze results and report product and in-process checking test results.

● Aid with process and product qualification activities.

● Aids during audit activities.

● Aid with product failure analysis.

● Create and keep data files and forms.

● Use documentation systems to research information and generate Change Requests.

● Aid in developing and qualifying test methods, data sheets, test fixtures, and testing equipment.

● Train peers on processes and methods.

● Initiate and aid in the investigation and disposition of nonconforming materials, designs and/or systems.

● Review device history records (DHR) and acceptance records to ensure all activities in the Device Master Record (DMR) are complete and approved.

● Update databases and spreadsheets used to track, monitor, and report department activities.

● Use the inventory and traceability management systems to transact and research material.

● Communicate with a wide variety of BSC personnel in and outside of the plant. Page 3 of 3

Tendyne/Abbott Dec 19, 2017, to Dec 21, 2018

Document Control Specialist

● Maintain change control and deviation processes for SOP’s, Device History Files, Test Methods, Validation Protocols/Reports, and other GMP documents.

● Perform DCO Pre-Review to assure compliance with Quality standards.

● Perform and ensure effective implementation of document control functions, including document logging, tracking, processing, review, distribution, and release and archiving of documents.

● Review Design History File (DHF) to assure compliance with QMS requirements.

● Assist with CAPA system administration by supplying guidance to CAPA owners and reviewing CAPA documentation.

● Actively take part in internal and External audits and preparation

● Quality Assurance procedures and policy maintained and reviewed regularly.

● Coordinate the revision, review, approval, and obsoleting of GMP documents.

● External Standards Remediation

● GAP analysis for Supplier Qualifications

● Clinical study report review

St. Jude Medical/ Abbott Jun 5, 2015, to Mar 27, 2017 Quality Technician

● Windchill used Daily.

● Perform review of History Records and Submit Certificate of Conformance

● Initiate & follow up ICS (Internal Customer Signal)

● Assure compliance with customer requirements and company standards.

● Actively take part with Quality System checks at other facilities/Divisions Nelson Numeric. Nelson Numeric June 5, 2013, to May 29, 2015

Quality Inspector

● Performs Internal Audits AS9100

● Interact with all functional areas.

● In-process and Final inspection throughout the machine shop

● Worked with Blueprints daily.

● Used precision measuring devices.

Medtronic OCT 1996 to OCT 2001

Quality Supervisor

● Track and keep corrective action database.

● Trained and supervised staff auditors in all aspects of the audit process

● Perform and ensure effective implementation of document review functions, including document logging, tracking, processing, reviewing.

● Recommended changes and improvements to cooperate and divisional management.

● Followed FDA compliance and good manufacturing practices.

● Actively take part in Internal audit at other facilities/Divisions

● Gather and report various performance metrics for quarterly Management Review meetings.

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