Summary
Overview
Work History
Skills
Certification
Timeline
Generic

Jessica Reynolds

Loomis,NE

Summary

Experienced Quality/Operations Implementation Specialist with expertise in quality assurance, regulatory compliance, manufacturing and project management. Skilled in leading cross-functional teams and implementing efficient processes to drive successful change control initiatives. Committed to executing all changes in a compliant and effective manner. Strong leadership and dedication to continuous improvement. Results-driven project management professional with a focus on team collaboration and delivering impactful outcomes. Proficient in coordinating complex projects, ensuring timely completion, and adapting to changing requirements. Proven skills in leadership, strategic planning, and stakeholder communication. Reliable and flexible in dynamic environments.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Plant Project Lead - Rebrand

Embecta
04.2024 - Current

· Employ project management principles at the plant level including gathering project requirements, project planning & execution, stakeholder management, communication planning & execution, coordinating meetings, and project monitoring task status & reporting up.

· Coordinate and contribute to the SKU execution plans. Responsible to engage cross functional SME’s to contribute to the project plan of each plant op’s functional area (manufacturing, supply chain, procurement, quality, engineering). Works with Program Management to synthesize functional plans and identifies critical interdependencies to drive successful execution of the project.

· Guides the successful completion of tasks by effectively organizing, communicating, and motivating a highly skilled cross functional team.

· Follow processes and tools to track execution of planned tasks.

· Ensure that plant stakeholders are up to date on status of each SKU. Responsible to escalate critical business decisions and risks in a timely manner.

· Works with plant SME’s to identify issues and recommend solutions to complex problems which require the regular use of ingenuity and creativity.

· Represents the manufacturing plant as a prime contact on integrating tasks and projects as needed.

· Communicate gaps and constraints on resources that impact achieving project goals.

· Clearly articulates complex updates in a simplified manner to leadership.

· Align plant stakeholders to the plant execution plan.

· Provides regular updates to keep stakeholders informed, including communicating up through the project leaderships and across their respective plant

Quality Systems Specialist

embecta/BD
04.2019 - Current
  • Member of SAP S4 Hana Implementation Team that is responsible for standing up new ERP system
  • Along with other key stakeholders, identified and tested key elements of system that would need to be implemented to ensure minimal disruption to the business
  • Stakeholder in new PLM vendor selection process, providing system requirements and organizational feedback
  • Lead process to identify and collect manufacturing master data for sustaining graphics and labeling changes
  • Establish change feasibility of packaging/graphic changes for manufacturing plant by interfacing with appropriate technical SMEs in support of 200+ SKUs
  • Coordinate SAP transactions across Materials, Scheduling/Planning, Engineering and Quality for Change Request effectivity and release
  • Support continuous development of Quality master data process with complete linkages with BOMs, Specifications and Inspection Plans
  • Subject matter expert for plant manufacturing processes in global cross functional meetings for project planning and execution

QDMS Business Administrator

BD
11.2011 - 04.2019
  • Worked in conjunction with corporate R&D, Packaging and Quality engineers to ensure ERP data was correct for all ECR/Os submitted for change
  • Created plant ECR/Os ensuring all affected and support documentation accounted for in change record
  • Member of SAP 6.0 implementation team for Document Management System and acted as DMS Implementation Lead for subsequent wave go-live
  • Fostered strong rapport with stakeholders through consistent follow-up and communication

Quality Clerk

BD
08.2011 - 11.2011
  • Maintained document data load spreadsheet for Document Management System upgrade
  • Ensured all applicable documents listed in appropriate part breaks in Bills of Material
  • Updated ERP system as necessary to build Device Master Records in support of 250+ SKUs
  • Prepared metrics for ECO routing times, including document review, document approval and ECO approval

Skills

  • Ability to lead cross functional teams
  • Project management
  • Knowledge of regulatory requirements for medical devices
  • Experience with FDA and ISO standards
  • Excellent communication skills
  • Strong problem solving skills
  • Analytical skills
  • Training and development of stakeholders
  • Change control processes
  • In depth understanding of medical device development processes
  • Design-control
  • Risk-management
  • Validation

Certification

CM2 Comprehensive Certification, Institute for Process Excellence, 12/01/23

Timeline

Plant Project Lead - Rebrand

Embecta
04.2024 - Current

Quality Systems Specialist

embecta/BD
04.2019 - Current

QDMS Business Administrator

BD
11.2011 - 04.2019

Quality Clerk

BD
08.2011 - 11.2011
Jessica Reynolds