Customer Service Medical Device

Lakivia Bellamy

**** ********** ***** ** *******.*******@*****.***

678-***-**** Home

Lawrenceville, GA 30044

678-***-**** Cell

PROFESSIONAL SUMMARY

A medical device professional with experience working in fast paced

environments demanding strong organizational, technical and interpersonal

skills. Successful tenures in manufacturing systems training, continuous

improvement, pharmaceutical manufacturing and quality control. Strong

knowledge of ISO 13485, 21 CFR Part 820 Quality System Regulations, and

medical device directives. Recognized for bringing leadership, enthusiasm,

creativity to projects and presentations. Detail oriented and resourceful

in completing projects, performing multiple tasks effectively utilizing

strong MS Office skills. Takes a business partner approach to maximize

results aimed at achieving organizational, team and individual objectives.

Capabilities include:

Document Control Project Management Calibration

Process Improvement Problem Solving Facilitator/Train the

Quality Customer Service and Trainer

Inspections/Audits Relations Technical Writer

Procedure Training Change Control/CAPA Inventory Control

PROFESSIONAL EXPERIENCE

Bellamy Enterprise, Nov 2014 - Present

Remote/Virtual

Self Employed

. Write customized workforce training for businesses in the state of

Georgia

. Design and develop instructional material/standard operating

procedures for clients from a wide range of industries including

beverage, food, biotechnology, medical device, packaging, industrial

coating and retail

. Design and develop training material, work instructions, instructional

guides, participant guides, and powerpoint presentations, which

support companies' technical products

. Create activities, simulations, exercises, and quizzes for employees (eg.

participant guides)

. Develop and deliver presentational training sessions on an as-needed

basis using the ADDIE

Method

ALCON Laboratories, Jul 2001 - Aug 2013

Duluth, Georgia

(Formerly CIBA VISION)

Sr. Document Management Specialist (11/2009 - 08/2013)

. Maintained and improved the flow of 200+ controlled documents

. Managed historical archives of controlled documents, electronically

and hard copies

. Maintained the data management process related to document control,

CAPA, complaints, audits, and calibration

. Allocated compliance materials for training staff and ensured

personnel remained up-to-date on new

and revised standard operating procedures

. Created, proposed and presented Change Request packages (CR) for

Change Control Board (CRB) approval, which served as benchmark process

changes throughout the department

. Supported yearly Regulatory and Corporate Audits as a database

Administrator maintaining documents, providing functional documents,

and contacting subject Matter Experts for interviews when needed to

resolve information needed

QA Records Auditor Batch Records Review (07/2008 -11/2009)

Reviewed Device History Records for all products and ensured that

documentation met quality requirements

Checked product within the non-conformance database to ensure quality of

the product before

releasing to distribution

Prepared and Filed Device History Records and sent to offsite vendor

Assured Device History Records where audited, and corrections where made as

required

Maintenance and integrity of the Device Master Record, Design History File,

Product History Record and Quality System documentation

Printed and verified bag labels that identified products/packaging.

distribution

Machine Operator - Manufacturing Unit (11/2004 - 11/2009)

Operated automation line to produce class II and III medical devices ( e.g.

Focus Night and Day,

O2 Optics, and Everest Lenses)

Operated and maintained molding machine to produce molds for the lenses

Performed Set-up and Targeted machine prior to each work orders

Inputted and verified data for daily work orders into the computer

management system

Lens Inspector - Manufacturing Unit (07/2001 - 11/2004)

Ensured that the medical device meet all quality and design specification

Utilized calibrated optical inspection equipment (Nikon) to accurately

inspected, and recorded results

into a Device History Record folder

Performed quality checks for defects within the lenses, identifying quality

non conformance

EDUCATION

American InterContinental University, Atlanta, GA

Bachelors of Business Administration, Health Care Management

Strayer University, Atlanta, GA

Master of Science Degree in Public Administration

JOB RELATED TRAINING

Essential Leadership Skills

Time Management & Organizational skills

Thinking Outside the Lines for Business Leaders and Managers

Project Management

CERTIFICATIONS

Privacy and Insurers Security Awareness Part I and II

Privacy and Health Care Employees

Privacy and Insurers

Privacy and Business Associates

Contact this candidate