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Sr Configuration Assurance Supervisor Resume Example

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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Summary

Motivated Senior Configuration Assurance Supervisor eager to contribute to team success through hard work, attention to detail and excellent organizational skills, as a Document Control Manager. Results focused with a clear understanding of the document control processes, supporting projects from development throughout the product life cycle. Experience with document controls/processing and knowledge in Quality Management System Regulations, Project Management and Design and Development. Unsurpassed work ethic with a drive to succeed and motivated to learn, grow and excel in a multi-industry corporation.

Skills
  • Document Management
  • Agile PLM, SAP, Cornerstone
  • Problem solver, critical thinker, active listener
  • Technical Writing / Editing
  • Attention to detail
  • Customer Service
  • Teamwork / Collaboration
  • Organized and ability to prioritize
  • Leadership skills
  • Microsoft SharePoint
Work History
07/2019 to Current
Sr. Configuration Assurance Supervisor Medtronic City, STATE,
  • Managed a team of 9 analysts to support Diabetes business unit
  • Reduced the rejection rate for documents and parts through Agile PLM from 51% to 23%
  • Responsible for saving the company millions of dollars in revenue with prioritizing and managing business critical needs
  • Planned and managed configuration of documentation, including drawings, labels and artwork, as well as parts and bills of materials, associated with developing and manufacturing devices throughout product lifecycle
  • Managed a team of analysts to help support critical to mission launches, as well as OUS deliverables, per project plan with no delays to Document Control support
  • Drove release of various drawing and document types related to design, engineering specifications, manufacturing, quality systems, business system software and tooling/equipment through collaboration with functional approvers and documentation authors
  • Collaborated with all functional groups, such as Quality, Regulatory, Supply Chain, Engineering, Manufacturing, Marketing, Finance, Supplier Quality and IT, as well as with manufacturing site representatives from Juncos, Puerto Rico and Chengdu, China
  • Analyzed situations within defined, standard business procedures and practices, for finding readily obtainable configuration management solutions to problems of moderate scope
  • Ran monthly reports to ensure the team was trained on time to most current revisions of procedures, in order to be compliant with requirements and processes
  • Conducted training to various business functions, to help users navigate work instructions and Agile PLM, to reduce rework cycle times, in order to release documentation more effectively
  • Participated in continual process improvement A3 discussion and proposals to support change control and procedure updates
  • Experience with CAPA investigations and Lean Sigma DMAIC problem solving
  • Integral core team member, involved with preparing and training for migration from one product lifecycle management process to another
  • Participated with on-site evaluations, internal audits and customer surveys
  • Led Document Control team in delivery of business projects per plan
07/2018 to 07/2019
Sr. Configuration Assurance Analyst Medtronic City, STATE,
  • Processed change orders in compliance with applicable procedures that support compliance with regulations and standards pertaining to medical device quality system change management
  • Reduced the rejection rate for documents and parts through Agile PLM from 75% - 51%
  • Provided direction and guidance to change order process and worked with change originators to maintain clear, concise and valid documents throughout
  • Collaborated with other configuration management groups and businesses
  • Processed parts and documents in a timely manner according to requirements and procedures in order to support business requirements
  • Assisted internal customers in document formats and styles
  • Responsible for leading data entry integrity when transferring changes to product data in multiple systems
  • Analyzed proposed changes of product design to determine effect on overall product and system.
08/2016 to 08/2018
Configuration Assurance Analyst Medtronic City, STATE,
  • Processed change orders, in compliance with applicable procedures that support compliance with regulations and standards pertaining to medical device quality system change management
  • Processed up to 20 changes a day to increase productivity
  • Provided direction and guidance in the change order process and worked with change originators to maintain clear, concise and valid documents throughout
  • Collaborated with configuration management groups and businesses
  • Processed parts and document changes in a timely manner according to requirements and procedures in order to support business requirements
  • Drove and facilitated the approval and release of documentation according to project schedules, including the resolution of resource issues
  • Assigned parts and processed numbers and assisted internal customers in document formatting and styles
  • Responsible for ensuring that the best practices of part/document change management are followed
  • Responsible for data entry integrity when transferring changes to product data in multiple systems
  • Contributed to problem solving/continual improvement discussions with regards to change control process, including the impact of changes and taking the initiative to recommend process improvements
Education
Expected in 1995
Bachelor of Arts: Psychology
California State University - Northridge - Northridge, CA,
GPA:
Certifications

CAPA training certification

Lean Sigma

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Resume Overview

School Attended
  • California State University - Northridge
Job Titles Held:
  • Sr. Configuration Assurance Supervisor
  • Sr. Configuration Assurance Analyst
  • Configuration Assurance Analyst
Degrees
  • Bachelor of Arts