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Customer Service Quality Assurance

Location:
Charlotte, NC
Posted:
July 08, 2014

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Resume:

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

C ONTROL, EDUCATION AND OFFICE ADMINISTRATION

S KILLS

Bilingual

( Spanish)

Advanced

C omputer Skills

HR Skills

Executive

A ssistant

Travel

A rrangements

OSHA

FDA

GMP

GDP

HIPPA

ISO 13485:2003

Radiation Safety

B renda L. Miller P age 2

EXPERIENCE

Quality Coordinator ( Short Assignment)

0 6/14-

DNP- Concord, NC

Track Customer complaints and CAPA.

First Article Inspections.

Inspected products to determine disposition.

Inspected products to verify meets product specifications.

Write and edit Work Instructions and SOP.

QUALITY ASSURANCE DOCUMENT CONTROLLER & TRAINING COORDINAT

Eckert & Ziegler, BEBIG, Inc. -

1 0/11 / 03/14

Electronically management, coordination, implementation, control and

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

Forms.

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

document distribution; and prevent use of obsolete documents, facilitati

Issued controlled unique reference numbers to support relevant QMS ac

Processed Batch Records, Validation Documents, Miscellaneous R

Specifications.

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

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

product release.

Collected, analyzed data from test results, generated regular repo

updated all quality data, license and manual books.

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

regulations.

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

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

QUALITY CONTROL COORDINATOR

Visual inspection of medical devices packaging surfaces and packaging

and free of obvious cosmetic defects.

Inspection of labels applied in order to maintain traceability during steril

Review of traveler documents to ensure accuracy of quantity, rev

specifications.

Verify the presence and location of required medical devices, accord

product documentation (drawing, assembly procedures, and radiograph)

Process medical devices reject, mark the locations of observe defect

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

Reviewed outgoing material to ensure attachments, dates, and signatu

accurate.

Assembled and maintained current charts and provides clerical/ad

including the composition and preparation of routine correspondence.

Completes a broad variety of administrative tasks including: managing

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

p acking.

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

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

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

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

Monitored component requirements and delivered materials to line as needed.

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

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

r ules governing students.

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

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,

r eports and legal documents.

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

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

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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