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Quality Engineer

Location:
Greenwich, CT
Posted:
July 28, 2013

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Resume:

GARY STUART

** *** ****, *********, ** *****

Home: 518-***-**** Cell: 518-***-****

ab9mzi@r.postjobfree.com

PROFESSIONAL SUMMARY

Dependable Quality Engineer bringing management experience

and a willingness to take on added

responsibility to meet tight deadlines. Enthusiastic team

player with a strong work ethic and advanced

complex problem solving skills with 23 years of disposable

medical device manufacturing experience.

SKILLS

Auditor Performed Internal & Supplier

Audits

Quality System Improvement Project Management

CAPA Cause and effect analysis

AutoCAD 13 Production, Tooling &

Facility Drawings

Strong leadership abilities

WORK HISTORY

Quality Engineer March 2013 to Present

Bates Industries, LLC - South Glens Falls, N Y

Assure all products manufactured at Bates Industries, LLC are

manufactured in accordance with

Company and applicable regulatory policies to assure a safe and

effective product is supplied to

the customer.

Create and update department work instructions and reports on a

regular basis.

Manage product quality to guarantee compliance with quality policies,

procedures, systems FDA

compliance and ISO standards.

Support all design efforts and implementation of

new products.

Investigate Customer Complaints

Corrective Action and Preventative Actions (CAPA)

AutoCAD and Drawings files.

Investigate and implement ideas for quality improvement, increased

productivity and cost

reduction.

Quality Manager October 2002 to March

2013

Bates Industries, LLC - South Glens Falls, N Y

Created and updated department work instructions and

reports on a regular basis.

Managed product quality to guarantee compliance with

quality policies, procedures, systems FDA

compliance and ISO standards.

Implemented performance, quality and efficiency

measures to achieve aggressive company

goals. Support all design efforts and implementation of

new products.

Investigate Customer Complaints

Managed the Corrective Action and Preventative Actions

(CAPA)

Managed the AutoCAD Drawings files.

Investigate and implement ideas for quality

improvement, increased productivity and cost

reduction.

Quality Assurance & Warehouse Supervisor September 2000 to May 2003

Hudson RCI - Argyle, N Y

April 1999 - October 2002

Investigated and implement ideas for quality

improvement, increased productivity and cost

reduction.

Verified that all process control parameters were being

documented and followed through quality

inspections.

Planned, directed, coordinated and assigned manpower to

meet aggressive production schedules.

Directed improvements in safety, product quality,

service and cost efficiency.

EDUCATION

Nashoba Valley Regional 2004

Westford, MA

High School Diploma: Drafting

UBM Canon June 2011

Working with FDA

Oriel Stat A Matrix July 2012

CAPA Programs for the Medical Device Industry



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