A H IGHLY MOTIVATED, EXPERIENCED PROFESSIONAL WITH SKILLS IN QUALITY ASSURANCE, QUALITY

C ONTROL, EDUCATION AND OFFICE ADMINISTRATION

S KILLS

Bilingual

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( Spanish)

Advanced

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C omputer Skills

HR Skills

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Executive

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A ssistant

Travel

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A rrangements

OSHA

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FDA

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GMP

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GDP

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HIPPA

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ISO 13485:2003

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Radiation Safety

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B renda L. Miller P age 2

EXPERIENCE

Quality Coordinator ( Short Assignment)

0 6/14-

DNP- Concord, NC

Track Customer complaints and CAPA.

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First Article Inspections.

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Inspected products to determine disposition.

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Inspected products to verify meets product specifications.

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Write and edit Work Instructions and SOP.

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QUALITY ASSURANCE DOCUMENT CONTROLLER & TRAINING COORDINAT

Eckert & Ziegler, BEBIG, Inc. -

1 0/11 / 03/14

Electronically management, coordination, implementation, control and

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o f Quality System this include: Standard Operation Procedures, W

Forms.

Approve, review and update documents; make changes and identify re

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document distribution; and prevent use of obsolete documents, facilitati

Issued controlled unique reference numbers to support relevant QMS ac

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Processed Batch Records, Validation Documents, Miscellaneous R

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Specifications.

Tracking and update logs for: Training Matrix, Training Plan, em

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descriptions, CAPA system, non-conforming, change control, comp

product release.

Collected, analyzed data from test results, generated regular repo

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updated all quality data, license and manual books.

Supported Internal, External Quality Auditors., followed FDA, NR

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regulations.

Assisted in the preparation of Technical Files, DMR, PFMEA and flow

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c lerical, e-mails, preparing labels, mailing, customer service and faxing.

QUALITY CONTROL COORDINATOR

Visual inspection of medical devices packaging surfaces and packaging

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and free of obvious cosmetic defects.

Inspection of labels applied in order to maintain traceability during steril

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Review of traveler documents to ensure accuracy of quantity, rev

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specifications.

Verify the presence and location of required medical devices, accord

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product documentation (drawing, assembly procedures, and radiograph)

Process medical devices reject, mark the locations of observe defect

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and segregate nonconforming medical device to Material Review Board

Manufacturing Engineering and Quality Director.

ACCOMPLISHMENTS

D irectly responsible for creating, distributing and performing training verific

procedures, work instructions and forms. Interfaced regularly with the UK Quality

r ecommended document control system improvements. Met all corporate timelines

resulted in our company being one of the first to implement the Quality System

d uring monthly worldwide company presentations.

0 8/08 -10/11

ADMINISTRATIVE ASSISTANT

Yale Behavioral Health Services - Hamden, CT

Filled and updated medical records for treatment plans and assists in ph

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Reviewed outgoing material to ensure attachments, dates, and signatu

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accurate.

Assembled and maintained current charts and provides clerical/ad

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including the composition and preparation of routine correspondence.

Completes a broad variety of administrative tasks including: managing

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calendar of appointments; composing and preparing correspondence.

B renda L. Miller P age 2

QUALITY INSPECTOR SUPERVISOR 1 0/04 – 02/08

American Plastic Products- Waterbury, CT

Determined that all units contained corresponding kits and were cosmetically free of defects prior to

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p acking.

Inspected assembled products ready to ship to conform that they met company standards and customer

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s pecifications. Mentored teams to analyze the quality of the products assembled.

Performed production/packaging start-up and continuous monitoring of the line operation.

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Assigned line workers to their position on the line and provide instructions as required.

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Monitored component requirements and delivered materials to line as needed.

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Rotated workers, and directed and led line operation to assure production goals were achieved.

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TEACHER ASSISTANT 0 8/01 – 05/02

Department of Education - Moca, PR

Designed and planned daily lessons for a class of 30 students, and enforced administration policies and

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r ules governing students.

Observed students' performance and recorded relevant data to assess their progress and facilitated

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r egular parent conferences.

LEGAL SECRETARY 0 8/97 – 06/99

Luis A. Loperena, Lawyer Buffet -, Moca, PR

Conserves attorney’s time by reading, researching, reviewing, verifying, and routing correspondence,

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r eports and legal documents.

Drafting documents; collects evidences, initiating telecommunications and manage lawyer calendar.

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Organize and maintain law libraries, documents, and case files.

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EDUCATION

Master of Public Administration ● Health Services 6 s emester hours 0 6/11

K eller Graduate School of Management

Bachelor of Science ● Business Administration/Management 0 5/10

University of Phoenix

B achelor of Science ● Natural Sciences 115 semester hours 12/02

University of Puerto Rico

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