Engineer Manager

KATHERINE M. WILLIAMS

**** ******** ******** ***** ******, MD 20723 202-***-**** ****************@*****.***

EDUCATION

Bachelor of Science, Mechanical Engineering, University of Cincinnati, June 1995

Master of Business Administration, Franklin University, August 2002

Master of Education, Curriculum and Instruction, George Mason University, January 2011

EXPERIENCE

Deputy District Director 2012 – Present

Food and Drug Administration - Baltimore, MD

Manage operations for field office that includes an Administrative Branch, Compliance Branch, Investigations

Branch and a Quality Management System

• Formulates comprehensive short and long range work plans and budgetary proposals necessary for

a district office's assigned portion of the nationwide and regional work plan

• Establishes and maintains liaison and cooperative relationships among national public health

organizations, other government agencies, academic institutions, and state and local health

departments

• Maintains effective communication with regulated industry, consumer groups and the general public

to foster understanding of the FDA's programs activities and regulations

Quality System Manager 2010 – 2012

Food and Drug Administration - Baltimore, MD

Implemented quality management system in accordance with Office of Regulatory Affairs (ORA) directives

• Conducted audits and performed gap assessments

• Managed all aspects of quality system including document control, control of records, complaints,

nonconformances, preventive actions, corrective actions, and continual improvement

• Trained and coached staff

Consumer Safety Officer 2009 – 2010

Food and Drug Administration - Silver Spring, MD

Ensured that manufacturers of cardiac rhythm and electrophysiology devices (CRED) complied with

Center for Devices and Radiological Health’s (CDRH) regulations

• Reviewed manufacturing changes associated with pre-market and post-market devices

• Evaluated and classified recalls

• Investigated trade complaints

• Drafted warning letters

Senior Manager, Project Planning and Business Development 2007 – 2009

Otsuka America Pharmaceutical, Inc. - Rockville, MD

Managed resources for the Medical Device Division’s commercial products

• Led cross-functional initiatives to establish duty-aligned training curriculums, conduct risk

assessments, qualify suppliers, and improve quality system

• Provided subject matter expertise for CAPA and complaint handling processes

• Oversaw process changes for components, manufacturers and packaging contractors

KATHERINE M. WILLIAMS

9627 Hammonds Overlook Court Laurel, MD 20723 202-***-**** ****************@*****.***

• Supervised Business Development Coordinator

Senior Quality Engineer 2004 – 2007

Eli Lilly and Company - Manassas, VA

Provided quality oversight during construction, commissioning and qualification of new insulin injection

device manufacturing facility and managed staff and operations of Document Control Center

• Reviewed procedures, quality plans, validation documentation for new

equipment

• Recruited employees and led training classes for quality control laboratory

staff

• Managed document control processes for GMP and project files

• Performed audits to ensure compliance with corporate and local SOPs

• Ensured timely processing of over 1500 documents for more than 80

customers

• Supervised quality control laboratory for incoming materials and finished

devices

• Performed batch record review and second person verification

• Conducted laboratory investigations for out-of-specification results and

deviations

• Improved operations for Incoming Inspection and Finished Goods

Inspection laboratory

Process Control Manager 2003 – 2004

American Red Cross – Washington, DC

Established department within Quality Assurance Blood and Plasma Operations

• Analyzed data for investigations, operational trials, and process improvement

initiatives

• Used expertise in data mining and SPC to develop new investigation

procedures

• Conducted effectiveness checks by designing and executing data

warehouse queries

• Received Spirit of Excellence Awards for technical contributions to consent

decree compliance

Quality Manager 2000 – 2002

Neoprobe Corporation - Dublin, OH

Ooversight for $4M supply chain for gamma detection devices

• Provided oversight for product development, validation, verification and engineering pilots

• Collaborated with regulatory on validation plans, quality plans, and regulatory submissions

• Administered supplier certification program and nonconforming material review process

• Created FMEAs and conducted hazard analysis for reusable probes

• Led internal quality system audits and external supplier audits

• Initiated/investigated corrective and preventive actions (CAPA)

Development Engineer 1997 – 1999

Arthrocare Corporation – Sunnyvale, CA

Led projects during conceptual and feasibility phases of new radiofrequency devices

KATHERINE M. WILLIAMS

9627 Hammonds Overlook Court Laurel, MD 20723 202-***-**** ****************@*****.***

R&D Engineer 1996 – 1997

Guidant Corporation – Santa Clara, CA

Demonstrated reliability and quality of cutter subassembly for ultrasonic atherectomy catheter

Process Engineer 1995 – 1996

Babcock & Wilcox Naval Nuclear Fuel Division – Lynchburg, VA

Obtained DOD Secret level security clearance to support fabrication of nuclear fuel components

PATENTS

U.S. Patent No. 6379351 - Electrosurgical method for the removal of pacemaker leads

U.S. Patent No. 6183469 - Electrosurgical systems and methods for the removal of pacemaker leads

CERTIFICATIONS & AFFILIATIONS

Certified Manager of Quality/Operational Excellence by American Society for Quality (ASQ)

Certified Quality Engineer (CQE) by American Society for Quality (ASQ)

Certified Quality Auditor (CQA) by American Society for Quality (ASQ)

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