Quality Assurance Medical Device

Federico Esquivel

***** ****** ***** • Northborough, MA 01532 USA

812-***-**** • ********@*****.***

SUMMARY

** ***** ** ********** ** the medical device, pharmaceutical, consumer goods and electronics industries. Extensive

experience in Quality Assurance and GMPs in FDA regulated industries. ISO 9001, ISO 13485 and Quality Systems

including CAPA and NCR, Production Planning and ERP systems

EDUCATION

BS - Industrial Engineering 1999

Universidad Internacional de las Americas, San Jose, Costa Rica

EXPERIENCE

INTEGRA LIFE SCIENCES, Burlington, MA 3/2011 - Present

Minimally invasive medical device manufacturer

Quality Engineer

• Responsible for Quality Assurance Process for Brain Light Source and Console equipment

• Assure all light source products meet Integra Life Sciences quality standards, GMPs and FDA regulations

• Assure that all procedures, equipment and tools are updated and validated according to site specifications

• CAPA and NCRs individual contributor, including initiation, investigation, establishing containment actions and

evaluating implementation effectiveness

• Develop application for quality assurance metrics/ trending analysis, continuously improving QA processes

MONROE COUNTY CASA INC, Bloomington, IN 1/2010 – 12/2011

Volunteer-powered program which provides representation in juvenile court for child victims of physical abuse, sexual abuse, and neglect.

Member - Board of Directors

• Serve as a voting member of the Board with authority and responsibility to develop goals, policies, and initiatives for

the conduct of Monroe County CASA, INC.

HOLOGIC INC, Costa Rica 6/2007 – 7/2009

Women’s healthcare medical diagnostics, surgical & imaging systems and surgical products manufacturer

Production Planning Superintendent

• Establish, analyze, and maintain an attainable MPS for all Products and Demand through in-depth knowledge of ERP

Systems, Master Production Scheduling and Capacity Planning

• Review Sales Order Shipments and consume the Forecast; Provide metrics for tracking actual sales to forecast as well

as actual production to forecast

• Review and establish implementation dates for Engineering Change Orders

• Ensure that design, implementation, test and maintenance methods/processes are developed and executed in a manner,

which supports Hologic Quality standards

• Strategy Planning and execution management of facility transfer representing the Materials Department

BOSTON SCIENTIFIC CORP, Costa Rica 7/2005 – 6/2007

Minimal invasive medical device manufacturer

Quality Assurance Supervisor 7/ 2006 – 6/2007

• Responsible for Quality Assurance Process for Polypectomy Value Stream (Snares products)

• Assure all products manufactured meet company quality standards, GMPs and FDA regulations

• Coordinate Quality Inspectors daily work, trained, coached and mentored peer and inspectors as needed

• Assure that all procedures, equipment/tools are updated and validated according to site specifications

• CAPA and NCRs individual contributor, including initiation, investigation, establishing containment actions and

evaluating implementation effectiveness

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Federico Esquivel

15108 Avalon Drive • Northborough, MA 01532 USA

812-***-**** • ********@*****.***

• Developed application for quality assurance metrics and trending analysis, continuously improving quality assurance

processes

BOSTON SCIENTIFIC cont.

Production Planner 7/2005 –7/2006

• Responsible for Master Production Schedule for Biopsy & Pulmonary products using SAP

• Provide analysis of capacity, manpower and develop tools and solutions in order to enhance planning process within

the company

• Coordinate raw materials with buyers to assure a smooth production

• Keep competitive indicators (adherence %, product volume & mix and service levels) in the DC

SARA LEE CORP, Costa Rica 1/2003 – 6/2005

Brand name consumer-goods and retail product manufacturer, formerly branded apparel

Materials Superintendent: Cartex & Gretex Plants 10/2003 – 6/2005

• Planning, Warehouse Area, Materials, Exp. /Imp. Cargo for Sara Lee Gretex & Cartex Plant

• Assure supplies availability, inventory control, On-Time Materials Order Process

• Reduce freight rates cost and product set up time, maintain low supplies and materials inventory according to Lean

Manufacturing techniques and Kaizen philosophy in order to impact overall cost

• Keep competitive indicators (adherence %, inventory accuracy, etc) regarding other plants in CA

Production Planning Coordinator: Gretex Plant 1/2003 – 10/2003

• Provide analysis of capacity/manpower; develop tools/solutions to increase productivity

• Coordinate introduction of new products and styles

STEIN LABORATORIES, Costa Rica 3/2002 – 12/2002

OTC and prescription drugs pharmaceutical developer and manufacturer

Planning: Institutional Market Group Leader

• Provide analysis of capacity, manpower and develop tools and solutions in order to increase productivity within the

pharmaceutical process

• Led the institutional market planning group in order to assure effectiveness of the production monthly game plan

regarding due dates, time frames

PYCON INC, Costa Rica 11/1998 – 2/2002

Manufacturer of printed circuit boards & electrical measuring instruments

Field Service Engineer at Intel Corp. (A6/T6): TIU Team Leader

• Group leader for the Pycon TIU (Test Interface Unit) operations at the Intel Site

• Provide analysis of the TIU Team performance indicators (MSBF, MTTR)

• Responsible for the Inventory Control

• Participate in the Task Force groups; Lead the development of reports requirements and new procedures (BKM’s) on

HVM sites (Costa Rica, Malaysia, Philippines and Arizona), define TIU Team members roles and responsibilities

COMPUTER PROFICIENCIES

• Windows Office (Word, Excel, Power Point, Visio, Outlook)

• AS/400, Lawson, Arena, Lotus Notes, SAP, Kronos, VBA (Macros), QAD MFG/PRO, Oracle

LANGUAGES

• Fluent Spanish, English and Italian

• Portuguese 50%

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