Operations Professional

Operational Management | Quality Systems | Financial Management

Operations Professional with over 15 years of extensive experience in the management of manufacturing, quality and general business operations including financial controls.  I am a self-motivated and goal-driven individual, with proven leadership skills and a solid track record of establishing strategic plans, determining priorities and implementing effective solutions within allotted time and resources.  I have extensive experience in leading corporate level project planning and team building with a focus on developing a highly dynamic and efficient organization.  I am adept at working within highly regulated environments, domestic and international, while ensuring compliance with established standards.

Areas of Expertise

Professional Experience

SonaCare Medical, LLC, Indianapolis, IN                                                                                2003 – October 2013

Class III Medical Device Manufacturing Company in the field of High Intensity Focused Ultrasound (HIFU)

Director of Operations – Led all Manufacturing and Operational functions – quality, financial, human resources, supply chain management, manufacturing, inventory, servicing, and IT – including strategic planning of goals and objectives and team development. 

 Operational/Financial

• Initiated manufacturing process review and development of a program to reduce manufacturing costs by over 40% per unit and reduction of production time by approximately 60% by resourcing of value added suppliers and developing lean in-house, GMP compliant, processes
• Led the establishment a new 24,000sqft GMP compliant manufacturing facility, research lab, inspection area, machine shop and engineering offices on time and under budget.  Managed all timeline and budget planning, resource allocations, interactions with all contractors and service suppliers and the development and execution of validation activities
• Negotiated supplier manufacturing and quality agreements, as needed, based upon the material/service being supplied; supplier base at SonaCare ranged from standard OTS materials to highly customized electronics assemblies
• Initiated communications with the state of Indiana to receive $400,000 in grants for job creation and training programs

• Initiated the development of effective personnel development program including formalized job descriptions, personnel evaluation programs and the implementation of standard review cycles to ensure personnel are meeting all expectations and ensure continued development of the team
• Managed annual financial reviews with external auditors and assisted in the development and review of year-end financial reports provided to the Board and shareholders
• Served as Board Secretary (Focus Surgery, Inc.) from 2003-2008 and managed communications and meetings; directly provided financial and manufacturing status reports

Quality

• Established Management Review process that specifically addressed quality objectives quantitatively to ensure clear trending evaluation and address improvement efforts
• Managed and developed quality programs ensuring continued certification to FDA 21CFR11, ISO 13485, Canadian Medical Device Regulations, European Medical Devices Directive 93/42/EEC Annex II and the Japanese Pharmaceutical Affairs Law
• Member of cross-functional Management Review, CAPA, MRB, Nonconformance and Complaint Handling boards
• Established effective Quality Control processes covering equipment maintenance and calibration, line clearances, and lean material/production flows (FIFO, 5S)
• Led the sourcing, validation and implementation of a corporate level electronic documentation system (eDMS) of all quality system related documentation compliant with FDA CFR 21 part 11 as well as relevant ISO and other regulatory requirements

• Member of cross-functional team focused on reduction of CAPA/Nonconformance cycle times; drove efforts to close/remediate all manufacturing related CAPAs to within established process guidelines and risk priorities
• Member of the senior leadership team driving the effort to implement FDA QSR requirements into the existing quality system as part of our ongoing PMA program

• Established risk based processes to ensure all suppliers were adequately reviewed based upon the material/service supplied; coordinated with Quality teams during onsite audits and in the review of any supplier corrective actions required

 GSC Manufacturing, Inc., Indianapolis, IN                                                                             2000 – 2003

Tier I Automotive Supplier of Precision Machined Components

 Senior Accountant/Human Resource Manager – Managed all Accounting and Human Resource functions for the organization; member of the company Quality team.
 

• Managed year-end financial reviews with external auditors/lenders
• Led accounting reviews resulting in a reduction of costs and recovery of prior overpayments
• Managed company’s payroll, training programs and benefit administration
• Led Quality internal auditing program to ensure compliance of the company’s QS-9000 program
• Member of company Management Review and CAPA boards
• Led the development and implementation of an electronic document management system (eDMS) for the company’s quality system
• Sourced and executed new online Payroll/ Human Resource system that eliminated inaccuracies, provided better information to employees and reduced processing time by over 50%

Noblesville Casting, Inc., Noblesville, IN                                                                                               1997 – 2000

Ductile Iron Producer for Automotive and General Industry

Controller/Purchasing Manager – Led multiple departments including Accounting, Purchasing, Human Resources and the Information Systems; Member of cross-functional ISO-9001 implementation team.                 

T.J. Maxx, Inc., Tuscaloosa, AL; Ocala, FL; Mobile, AL                                                        1989 – 1997

Store Manager – Managed all store activities including customer service, hiring and development of employees, shrink management, customer service and merchandising.

Education

Indiana University – Purdue University Indianapolis, Indianapolis, IN

• Bachelor’s Degree; Dean’s List

University of Alabama, Tuscaloosa, AL

Training:

• FDA Quality System Regulations (QSR/GMP) & Inspections
• Auditing Quality Systems for FDA & ISO Compliance
• Risk Management, ISO 14971 and FDA Requirements
• Design Control – FDA & ISO
• ISO 13485:2003
• Complaints, MDRs & Recalls for Devices
• Familiarity with Lean Manufacturing, 5S, Six Sigma methodologies