Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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DONNA WOODY

Hopkinton,MA

Summary

Experienced Senior Quality Supervisor at Boston Scientific in a multifaceted role. Highly motivated employee with desire to take on new challenges. Strong work ethic, adaptable, and with exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Effective communication and leadership abilities with a focus on fostering a culture of inclusion and embracing Agile Methodologies through collaboration with cross-functional teams. Ethical and honest with exceptional skills in process improvement and change management. Strong understanding of risk management process, as well as ensuring adherence to industry standards through effective quality management strategies. Adept at implementing & managing quality control systems, regulatory audits, collaborating with cross-functional teams both at home and in emerging markets. Proven history of complaint investigation AI reduction through implemented strategies with Patient and Client first approach. Motivated Quality Supervisor gifted at personally managing quality activities to ensure customer satisfaction.

Overview

19
19
years of professional experience

Work History

Senior Quality Supervisor, Complaint Investigations

Boston Scientific Corporation
Marlborough, MA
07.2018 - Current
  • Implemented RPA tools for automating rule-based, repetitive tasks.
  • Reduced AI requests made by regulatory agencies while serving on the Quality Writing Review Board.
  • Interacted with auditors from both within and outside the organization.
  • NCEP/CAPA owner.
  • Played a key role in achieving objectives through cross-functional project work.
  • Worked collaboratively across departments to meet common goals.
  • Implemented successful platform integration project.
  • Delivered onsite training to professionals in India, Philippines, and Costa Rica.

Senior Quality Engineer

Boston Scientific Corporation
Marlborough, MA
10.2016 - 07.2018
  • Complaint Investigations

Product Analyst I, II, Senior

Boston Scientific Corporation
Marlborough, MA
10.2008 - 10.2016
  • Complaint Call Center/Complaint Investigations

Quality Lab Supervisor

Aspen Aerogels
Marlborough, MA
01.2005 - 10.2008
  • Supervisor QA Labs at 2 sites.

Education

B.S. - Biology/Biochemistry

Framingham State University

Skills

  • ISO-13485 / 21 CFR Part 820
  • Corporate CAPA
  • Risk Analysis and Documentation
  • Biological Language Proficient
  • Collaboration & Teamwork
  • Biocompatibility of medical devices
  • Microsoft Office
  • Focused on quality
  • GCMS complaint management system
  • SAP
  • SAS analytical software
  • Global Workflow
  • Data Analysis SAS/Power BI/Excel Pivot
  • Staff Training

Accomplishments

  • Winning Spirit Award for support of integration team.
  • Above and Beyond Award for training in emerging markets.
  • Bronze Award for Shipping Cost Reduction.
  • Several Spot Awards for participation above and beyond.

Timeline

Senior Quality Supervisor, Complaint Investigations

Boston Scientific Corporation
07.2018 - Current

Senior Quality Engineer

Boston Scientific Corporation
10.2016 - 07.2018

Product Analyst I, II, Senior

Boston Scientific Corporation
10.2008 - 10.2016

Quality Lab Supervisor

Aspen Aerogels
01.2005 - 10.2008

B.S. - Biology/Biochemistry

Framingham State University
DONNA WOODY