D. Lucy Potter

About D. Lucy Potter

Effective communication and report writing skills. Good negotiation skills with…

Experience

1. Manager of Quality Assurance Auditing

   CorneaGen

   Jul 2021 — Present

   Responsible for all quality auditing aspects including all steps in the audit process to include internal audits, external audits, vendor audits and Partner audits. This role will assure that all CorneaGen sites meet or exceeds all Eye Bank Association of America (EBAA), ISO 13485, Federal Drug Administration (FDA), OSHA and CorneaGen standards. Essential Duties and Responsibilities: • Manages internal and external audit process • Develops annual audit plan and objectives, manages audit activities, and works with staff in the execution of the audit program. • Performs audits of internal and external operations, partners, and vendors to maintain a high level of quality and compliance with regulatory requirements. • Evaluates and recommends improvements to operational and quality processes and controls. • Notify managers of audit issues in a timely fashion. • Prepare reports of audit findings and recommendations in a timely fashion, develops action plans based on audit results to address the gaps and reviews with business units. • Maintains all audits, audit corrections and final reports for reference purposes. • Train, mentor and evaluate performance of audit assistants and other audit staff and provide appropriate feedback. • Develop continuous improvement initiatives to improve audit efficiency and effectiveness. • Assist in risk assessment and mitigation activities. • Communicate audit status via management report on regular basis. • Coordinate with the management and partners and vendors about audit practices and taking appropriate action on audit findings. • Assist in determining budget, timelines and resources for audit projects. • Communicate audit coverage and status to executive management. • Provide support to external auditors in audit execution. • Maintain high level of professionalism and competence in assigned duties. • Performs other projects and duties as assigned.

Education

• University of Phoenix

  Master of Science (MS), Business Administration

  2013 — 2013

• University of Phoenix, Campus

  Bachelors of Science, Business Management

  2005 — 2008

• IAHCSMM

  CRCST, CRCST 7th Edition

  2012 — 2012

• University of Phoenix

  MS, Industrial/Organizational Psychology

  2009 — 2013

Skills

• Capa
• Regulatory Affairs
• Change Control
• Coaching
• 5s
• Operations Management
• Iso 26000
• Continuous Improvement
• Root Cause Analysis
• Management
• Auditing
• Healthcare
• Strategic Planning
• Testing
• Sop
• Supply Chain Management
• Process Improvement
• Quality Assurance
• Customer Service
• Change Management
• Sewing
• Iso 31000
• Tqm
• Sdlc
• Kaizen
• Staff Development
• Microsoft Office
• Budgets
• Cross-Functional Team Leadership
• Team Building
• Process Engineering
• Iso 9000
• Product Development
• Iso 13485
• Project Management
• Lean Manufacturing
• Project Planning
• Dmaic
• Leadership
• Fda