Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Debra Blanc

Fairport

Summary

Seasoned Engineering Manager with 30 years expertise in manufacturing, supply chain, product governance, project management, continuous improvement and quality. Experience in technology, medical devices, call centers and construction. Skilled in planning, project management, CAPA, product governance, resource allocation and leadership. Demonstrated success in increasing compliance, adapting new Regulatory requirements, developing review systems and optimizing internal controls. Deliver results, provides attention to detail and problem-solving abilities with an innovative mindset. Thrives in fast pace situation and high pressure environments.

Overview

37
37
years of professional experience
1
1
Certification

Work History

Senior Business Systems Manager

LSI Solutions
02.2023 - Current
  • Increased team productivity by implementing streamlined processes and effective communication strategies.
  • Achieved departmental goals by developing and executing strategic plans and performance metrics.
  • Reduced operational costs through comprehensive process improvement initiatives and resource management.
  • Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Facilitated successful cross-functional collaborations for the completion of key projects, fostering strong working relationships among team members.
  • Drove operational efficiency through data-driven decision-making processes, leveraging analytics tools for informed strategy development.
  • Streamlined workflows by identifying bottlenecks in existing systems and proactively addressing these challenges through appropriate solutions implementation.
  • Managed and motivated employees to be productive and engaged in work.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Assisted in organizing and overseeing assignments to drive operational excellence.

Project Manager

Debra Pendergast Inc
03.2020 - Current
  • Enhanced traceability, processing, review and development of organization systems for tracking, permits and proposed change order requests.
  • Negotiated pricing and delivery schedules with vendors, drawing on thorough knowledge of housing industry and building practices.
  • Directed team of skilled workers to maintain quality, compliance and safety.
  • Planned, organized and managed crews and subcontractors through expert communication and handling of all work orders and purchase orders.
  • Interviewed and hired top contractor talent to promote on-time and under-budget project completion of $0.5 M
  • Mitigated risk, coordinated plans and updated specifications to maintain safety and OSHA compliance.

Quality Assurance Manager

LSI Solutions
03.2021 - 02.2023
  • Responsible for ensuring full compliance with regulatory requirements and standards that govern the design, development, manufacturing and distribution of our medical devices.
  • Implementation, enforcement and maintenance of the following processes: Regulatory Compliance, Internal Audits, and Corrective and Preventive Action.
  • Manages regulatory compliance of quality management system, through: managing the gap assessment process for all new or revised standards and regulations.
  • Ensuring an effective review of all changes to SOPs to ensure continued compliance to standards and regulations.
  • Leading compliance improvement initiatives
  • Lead quality system improvements projects.
  • Subject matter expert on management of electronic QMS software
  • Manage Training Specialist, Quality assurance Engineers and Quality Information Systems/
  • Manage software validations for corporation.

Corporate Business Project Director

Coast Professional Inc
10.2019 - 03.2020
  • Managed up to 6 corporate projects ($5M budget)
  • Created Project Plans and resources to ensure project milestones are met within expectations of timeline, quality, budget and regulatory compliance.
  • Monitored internal financial budgets to measure against projections.
  • Handled continuous project monitoring and management, including developing forecasts, tracking expenses and approving payments.
  • Brought projects in on-time and in accordance with budget and quality standards.
  • Managed SOPs to ensure continued compliance to standards and regulations.
  • Defined project plans and timelines, managed workflow and personnel and achieved completion deadlines on or before schedule.
  • Drove Agile technical projects spanning multiple business divisions and representing $1.2M in potential new revenues.
  • Introduced Continuous Improvement, Lean Six Sigma methodology and project management tools.
  • Developed internal auditing schedule for system provisioning to meet Department of Education regulations.
  • Developed test cases and performed validations for IT project deployment
  • Position effected by Covid 19

Cost Reduction Project Manager

Sunrise Systems
03.2019 - 10.2019
  • Consultant at Ortho Clinical Diagnostic to identify and implement cost reductions in manufacturing, supply chain and commercial operations of medical slides.
  • Improved profit margins by streamlining new product implementation process to enable implementation by approved country. Led cross-functional team to ensure operations, regulatory requirements (ISO 13485/14155), validations, marketing, and supply chain requirements were met. Completed pilot , implemented new protocols and implemented change resulting in $490K annual cost savings.
  • Motivated and encouraged team members to communicate more openly and constructively with each other.
  • Analyzed manufacturing data to determine root causes and revise operations protocol to reduce machine set up time and queues by 36%.
  • Positively impact organization through focus on continuous improvement and best practices.
  • Developed capacity model for resource planning and material scheduling for medical film operations
  • Monitored and consistently followed up with team members to ensure schedule and milestones were achieved successfully.
  • CAPA process contributor

Global Configuration & Policy Manager

Xerox
05.2009 - 05.2018
  • Managed and enforced global corporate policies and protocols for Multinational Packaging Standards and Product Configuration.
  • Developed new protocols and obtain approvals for new requirements and channels.
  • Managed all phases of IM and business projects from conception to completion; directed changes, costs, and implemented change management processes for corporate configuration and product life management systems.
  • Spearheaded communications with stakeholders to develop scope of diverse projects, made recommendations and worked in collaboration with multiple internal departments and teams.
  • Tracked performance and consistently prioritized tasks to ensure successful delivery of quality projects; facilitated strong communications and resolved critical issues.
  • LSS Black Belt utilizing continuous improvement processes and lean tools to drive change and management by facts.
  • Demonstrated leadership by making improvements to work processes and helping to train others.
  • Managed global team of project managers, configuration specialists, and product implementation analysis.
  • Led PLM Data Quality Project to enable systematically validate PLM data rules and improve data quality. Created requirements, timeline, test cases, validation cases and oversaw testing results. $ 3.4M project successfully implemented per schedule and under budget.
  • Responsible for developing and maintaining Master Validation Plan
  • Maintains accurate and compliant documentation to meet company, and regulatory expectations.
  • Developed budgets, oversaw P&Ls and achieved margin targets consistently to stay on track with growth plans.
  • Devised new and improved records management programs to organize and protect data.
  • Implemented and managed Managed Print Services database to provide consumables to support non-Xerox equipment owned by customers.
  • Managed Global Business Systems: Team Center, CDB, PDS, ICON
  • Managed CAPA for supply chain

Program Manager

Xerox
01.2002 - 04.2009
  • Managed cross -functional team responsible to understand country rules, laws and regulations, which promoted efficient development of legal parameters and process for ROHS and REACH regulations.
  • Identified business and system requirements for corporation to adhere to ROHS and REACH regulations.
  • Managed ROHS system testing and validation
  • Supported ROHS system integration implementation, user training and acceptance
  • Analyzed data, developed plan, created protocol for corporate snapshot and reporting of REACH corporate tracking.
  • Completed requirements to become certified LSS Black Belt including $3M corporate savings, statistical data knowledge, Minitab proficiency, LSS tools, story boards and mentoring.
  • Mentored 69 candidates to achieve LSS Green Belt certification in 28 month time period.

ERP Implementation Manager

Xerox
01.1997 - 01.2002
  • Evaluated diverse organizational systems to identify workflow, processes, communication and resource utilization issues for Oracle implementation and upgrades.
  • Evaluated current processes to develop improvement plans and re-engineering
  • Instrumental in management of Oracle Rollout to New products; provided technical leadership, created test scripts, oversaw user testing, conducted and documented system training for users.
  • Maintained roadmap and change requests for strategic and tactical initiatives.
  • ERP SME for configuration, inventory, WIP, MRP
  • Supported Global ERP platform for manufacturing, supply chain, and order to cash

Manufacturing Engineer & Supervisor

Xerox
05.1987 - 01.1997
  • Calculated overall production costs by evaluating material, labor and other expenditures.
  • Designed labor utilization standards to balance worker efficiency with employee satisfaction, increasing overall productivity and satisfaction.
  • Master Build scheduler for low volume copier focus factory supporting 11 production lines producing desk top copiers and printers.
  • Reviewed, validated and revised production schedules and engineering specifications.
  • Perform validation activities and provide training
  • Streamlined material handling and material flow procedures to reduce overall production times and shorten lead times.
  • Aligned production operations to meet higher standards and maximize returns.
  • Materials Manager for low volume copier focus factory supporting all material requirements and logistics.
  • Directed day-to-day operations focused on attainment of key business metrics, continuous improvement initiatives and 121-member team with related direct reports.
  • Applied performance data to evaluate and improve operations, target current business conditions and forecast needs.

Education

Bachelor of Science - Engineering, Industrial & Operations Research Mana

Syracuse University
Syracuse, NY
05.1987

Skills

  • Strong Problem Solving
  • Regulatory Compliance
  • Ability To Lead
  • Lean Manufacturing and Design
  • Innovative
  • Gap Analysis & Resolution
  • Measurement Tools
  • Processes And Procedures
  • Continuous Improvement
  • LSS Black Belt
  • Internal Auditing
  • Root Cause Analysis Expertise
  • Proficient MS Office, Project, Visio, Minitab
  • Excellent Communication Skills

Certification

  • Lean Six Sigma Black Belt
  • Leadership Through Quality Certification

Timeline

Senior Business Systems Manager

LSI Solutions
02.2023 - Current

Quality Assurance Manager

LSI Solutions
03.2021 - 02.2023

Project Manager

Debra Pendergast Inc
03.2020 - Current

Corporate Business Project Director

Coast Professional Inc
10.2019 - 03.2020

Cost Reduction Project Manager

Sunrise Systems
03.2019 - 10.2019

Global Configuration & Policy Manager

Xerox
05.2009 - 05.2018

Program Manager

Xerox
01.2002 - 04.2009

ERP Implementation Manager

Xerox
01.1997 - 01.2002

Manufacturing Engineer & Supervisor

Xerox
05.1987 - 01.1997

Bachelor of Science - Engineering, Industrial & Operations Research Mana

Syracuse University

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Debra Blanc