Quality Engineer

Amy

K.

Kent

** *********

Rd.

Cambridge,

MA

02138

(860)

460-

3158

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

PROFESSIONAL

EXPERIENCE:

Associate

Consultant

Halloran

Consulting

Group,

Inc.,

Waltham,

MA

12/2012

Present

Support

client

projects,

producing

high

quality

deliverables,

completing

tasks

by

required

deadlines,

and

ensuring

compliance

with

FDA

regulations.

• Current

project:

Improving

client

quality

system

by

harmonizing

SOPs

across

8

Operating

Companies.

• Manage

the

development

of

a

quarterly

newsletter,

providing

client

with

updates

on

the

latest

regulatory

news

from

the

FDA.

• Work

in

a

fast-

paced

environment,

balancing

multiple

projects

while

maintaining

high

quality

deliverables.

Associate

Quality

Engineer

Covidien,

North

Haven,

CT

5/2012

9/2012

Performed

Quality

Assurance

under

broad

direction

to

ensure

components,

finished

products,

and

processes

met

established

specifications.

Analyzed

material/processes

and

made

recommendations,

taking

action

to

correct

deficiencies.

• Completed

Corrective

Action/Preventive

Action

(CAPA)

and

Non-

Conformance

Reports

(NCR)

in

order

to

improve

the

quality

of

manufacturing

processes.

• Wrote

and

revised

Standard

Operating

Procedures

and

Quality

Plans,

subsequently

trained

manufacturing

and

QA

staff

to

ensure

company

compliance.

• Performed

internal

audits

of

all

Biosurgical

QA

and

manufacturing

processes.

Biomedical

Equipment

Technician

Volunteer

Lawrence

&

Memorial

Hospital,

New

London,

CT

8/2011

• Inspected

and

tested

medical

equipment

(defibrillators

and

NICU

incubators).

• Assist

medical

staff

with

the

setup

and

operation

of

biomedical

equipment.

ACADEMIC

PROJECTS:

Otoscope

to

Facilitate

the

Diagnosis

of

Otitis

Media

8/2011

5/2012

Our

team

designed

an

otoscope

to

house

LEDs

of

varying

wavelengths

that

would

pass

through

glass

filters

to

facilitate

the

observation

of

specific

structures

found

behind

the

tympanic

membrane.

Personal

accomplishments:

• Took

on

leadership

position

to

ensure

proper

communication

between

teammates

and

our

client.

• Used

University

machine

shop

tools

(milling

and

lathe

machines)

to

fabricate

entire

aluminum

framework.

COMPUTER/PROGRAMMING

SKIILLS:

C++,

LabVIEW,

MatLab,

Minitab,

Microsoft

Office

(Word,

Excel,

Powerpoint,

and

Project),

Simulink,

SolidWorks

PROFESSIONAL

AFFILIATIONS/CERTIFICATES:

Lean

Six

Sigma

Green

Belt

12/2013

EDUCATION:

University

of

Connecticut,

Storrs,

CT

5/2012

Bachelor

of

Science,

Biomedical

Engineering

Minor,

Materials

Science

and

Engineering

Contact this candidate