Quality Assurance Management

Janet Gallardo

*** * ******* ** *** Ridge Tn. ***30 734-***-**** ****************@*****.***

Objective

Quality Management/Auditor position allowing for parlay of demonstrated knowledge, organization, and management skills proven by 15 years of successful, employment in the Quality Assurance Field.

Profile

I am a sincere, loyal and dedicated individual who has a great deal of ambition and personal drive. Although I have extensive experience in the Medical Device Manufacturing Industry, I love to learn, and am always up to a challenge. I get along well with others, while also working efficiently on my own without a lot of direction. I am seeking a position where I can develop and excel while giving my best to an employer.

Skills Summary

Project Management

Report Preparation

Written Correspondence

General Office Skills Blue Print Reading

ISO Procedure Writing

Creating Work Instructions

Internal Auditor Use of a Comparator

Use of Hand Held Gages

Supervise Department Personnel

Professional Experience

INSPECTION

Able to use hand held gages (micrometer, Caliper, etc) to ensure product conforms to requirement.

Can use a Comparator, hardness tester; go/no go gages, etc to determine product conformity.

Knowledgeable at reading Blue Prints.

Able to perform First Piece Inspections at machine set-up, In-process floor inspection and final Inspections to ensure conformity.

Can use all required documentation to create a Manufacturing History Packet which conforms to ISO Standards.

Audit machine operator’s documentation.

QUALITY SUPERVISOR

Ensured all Inspection personnel are trained and have knowledge to perform job.

Responsible for ensuring Inspection Procedures and Processes are adequate for each manufacturing process.

Ensure Machine Operators understand and perform accurate in process inspections.

Compare Company manufacturing prints against customer print to ensure no deficiencies exist.

Disposition of product when a nonconformance has been detected.

Create work instructions for inspection processes and procedures.

Maintain traceability to raw material throughout manufacturing and shipping of product.

Audit manufacturing history packet before release of product

Certify and release product for shipping.

Calibrate all company and employee hand held gages.

Maintain a Calibration system for all gages and equipment.

Perform Gage R&R

Perform Capability Studies

MANAGEMENT REPRESENTATIVE

Manage and understand the standards needed to maintain a Quality Management System using

Q9001 and ISO 13485 Standards.

Lead company in its commitment and drive towards Quality Objectives.

Ensure all departments, processes, and procedures used maintain the integrity of the Quality

Management System.

Manage all customer complaints and Responsible for Preventative and Corrective Actions.

Perform Internal Audits and maintain system.

Guide third party auditors through system.

Employment History

Moeller Manufacturing Co. Inc. Aircraft -30100 Beck Road Wixom, Mi 48393

Quality Engineer-02/09/12 - 07/23/12

DIAMOND TOOL MFG. – 14540 Jib St. Plymouth, MI. 48170

Inspector/Qualtiy Supervisor/Management Representative, 1996 to 02/08/2012

UNISYS CORPORATION – Plymouth, MI.

Security Guard/Phone Operator, 1990 to 1993

UNITED STATES ARMY- Served various locations as a Military Police.

Education

HALLS HIGH SCHOOL – Halls High School TN.

Graduate:1983

SOME COLLEGE AS WELL AS ISO-9002 Training

ISO-9001 Training, ISO-13485 Training, Internal Auditor Training

CALIBRATION TRAINING

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