Andrea S. Feidler

**** ***** ****** ****, ************ 16511 Home 814-

***-**** **** 814-***-****

Email: acolyq@r.postjobfree.com

Career Summary:

EXPERIENCE MANAGER OF QUALITY, LEADERSHIP IN QUALITY

MANAGEMENT SYSTEMS SUCH AS ISO

Over 20 years of experience with Quality Management Systems

and Quality Supervisory Positions.

ISO Compliance Manager/Quality Surveillance

Specialist 05/2006- Present

CMI ENERGY

COORDINATE AND MAINTAIN PROGRAM RECORDS FOR CMI ENERGY'S

ISO-9001 PROCEDURE AND PROCESS DEVELOPMENT; PROVIDE SUPPORT

AS REQUIRED TO ALL DEPARTMENTS IN THEIR PREPARATION OF

THESE PROCESSES AND PROCEDURES.

Perform internal quality audits, including development,

distribution and execution of ongoing internal audits.

Support all departments in preparation for internal and

external audits and their adherence to ISO 9001 procedures.

Develop and maintain processes that ensure that Non-

Conformances and the Corrective Action items are identified

and resolved through interface with the appropriate

internal and external sources;

Develop, maintain and ensure appropriate application of

procedures and specifications for quality, manufacturing

and erection support, which ensure that customer and

company requirements are clearly communicated to our

suppliers and implemented in accordance with CMI Energy

requirements;

Develop and support Sales to ensure that all customer

requirements relating to manufacturability and quality are

reviewed during the proposal preparation stage of a

contract and negotiate valid customer requirements through

customer development;

Support Procurement and Project Management to develop

processes to ensure that all goods and services meet both

customer and quality requirements. Assist in the

establishment and maintenance of an approved supplier

listing through performing and/or coordinating the

performance of external audits to verify supplier

capabilities to ensure that subcontracted materials are

provided by qualified and approved suppliers;

Work with Project teams to perform surveillance of

suppliers and subcontractors to ensure that required

quality is maintained and quality issues are identified and

addressed in a manner that ensures adherence to project

schedules and reflects the customers' expectations and the

Company commitments; coordinate surveillance activities

with HRS to obtain and provide required surveillance

support

Senior Quality Systems auditor 01/2003- 05/2006

STERIS Corporation Erie, PA

* Plan/Do/Check/ Act on audits of all Quality Management Systems

on a predefined audit timetable.

* Conduct quality audits of manufacturing and related operations

areas in a systematic manner.

* Identify discrepancies and/or areas of improvement

through audit activities and provides feedback and

recommendations for corrections or improvement

* Assist in conducting and/or preparing for customer,

supplier, and service audits

* Conduct pre-production audits of FAIR results and make

recommendations for improvements and/or corrections

* Conduct quality system surveys and audits of suppliers

* Conduct internal audits of various manufacturing

processes

* Participate in product/component failure investigation

by auditing product processes

* Conduct audits on implementation of Engineering Change

Authorizations (ECA's) for Healthcare, Life Science, and

Defense & Industrial products

* Audit collected data in Device History Records for

regulatory compliance

* Provide inputs and outputs to top management regarding

improvement opportunities with Quality Management System

design, implementation and maintenance.

* Develop and maintain work instructions and procedures.

* Participate with Purchasing development of the annual

Supplier Audit Schedule

* Participate in Quality improvement teams.

* Participate in product qualification and configuration

audits.

* Participate in product release process for new products

through design and development teams.

* Assist develop & initiate quality plans for new product

lines

Maintains Corrective and Preventive Action (CAPA) System

* Examine process flow following implementation of

corrective action items to determine if such actions are

suitable and effective in problem correction.

QS-9000 Consultant 03/2002- 12/2002

Unity Rubber Cleveland, Ohio

* Lead Company team and train Managers to develop and document top

level procedures to meet standard requirements.

* Train all employees on standard requirements for QS-9000.

* Develop training guide for employees.

* Train internal auditors and develop internal audit schedule.

* Develop forms needed to support second level procedures

* Format procedures and work instructions.

* Create nomenclature for system documentation

* Develop and oversee calibration system to QS-9000 standard.

* Conduct pre-assessment audit of quality system.

Quality Systems Manager 01/2000-02/2002

Penn-Tech Rubber Girard, PA

* Management Representative for QS-9000 audits with third party

registrar.

* Responsible for writing Quality Manual and Procedures.

* Assist operators in development of work instructions and

document.

* Develop forms needed to support second level procedures.

* Format procedures and work instructions.

* Create nomenclature for system documentation.

* Train management as process owners and assist in procedural

writing.

* Train management on implementation of procedures.

* Develop training guide for QS-9000 training for all employees.

* Train all employees on QS-9000.

* Develop and oversee calibration system to QS-9000.

* Conduct Internal Audits.

* Oversee and manage internal audit system, develop and maintain

audit schedule.

* Supervise all QS-9000 activities.

* Responsible for daily quality activities.

* Responsible for three shift inspectors

ISO Coordinator/Document Control Admin. 03/1999-01/2000

Owens Brockway Erie, PA

* Responsible for writing Quality Manual.

* Assist department Managers to develop and document second level

procedures.

* Assist operators in development of work instructions and

document

* Develop forms needed to support second level procedures.

* Format procedures and work instructions

* Create nomenclature for system documentation.

* Develop training guide for training of all employees.

* Train all employees on ISO -9000 standard.

* Develop and oversee calibration system to standard.

* Oversee and manage internal audit system and conduct audits.

* Supervise ISO-900 activities.

* Develop ISO-9000 reference guide for operator utilization.

* Administration of Document Control System.

Technical Writer 12/1998-03/1999

Owens Brockway Erie, PA

* Create operator manuals which included instructions from machine

operation to maintenance of machines.

* Revise existing documents to present process

* Create a document control system for all operator manuals and

instructions

*

QS-9000 Coordinator 8/1996-12/1998

American Turned Products Erie, PA

* Responsible for writing Quality Manual

* Assist department Managers to develop and document second level

procedures

* Assist operators in development of work instructions and

document.

* Develop forms needed to support second level procedures.

* Format procedures and work instructions.

* Create nomenclature for quality systems documents.

* Develop training guide for QS-9000 training for all employees.

* Train all employees on QS-9000

* Develop and oversee calibration system to QS-9000 standard

* Conduct internal audits

* Manage internal audit system

* Supervise QS-9000 activities in multiple plants

* Main Assessment audit recommended for certification. (first

audit

no non-conformances)

Quality Control Manager 1993 to 1996

Trost Sheet-metal Works Erie, PA

* Managed and executed all aspects of quality control from

customer order entry to finished product.

* Supervised, created and implemented ISO 9002 certification

program and training for employees.

* Responsible for final approval of Quality Systems Manual.

* Extensive flow charting of manufacturing and inspection

processes.

* Interpreted customer blueprints and specifications.

* Provided technical support to sales, production, and customers.

* Maintained all documentation and records and ISO certification.

* Analyzed root cause to eliminate quality problems and implement

corrective action.

* Supervised inspectors, executed and defined duties, directed

inspectors to urgent production needs.

* Counseled, disciplined and measure employee performance and

document.

* Direct, assist or instruct production employee to help improve

quality or process.

* Verbal and written communication with employees and customers.

Quality Control Technician 1991-1993

Trost Sheet-metal Erie, PA

* Executed all aspects of inspection, including first piece, in

process and final inspection.

* Complete all documentation for quality control records.

* Calibrate measuring equipment to proper procedures and document

records.

* Prepare detailed inspection reports

* Assist QC Manager in MRB review and implement corrective action

Machinist 1990-1991 and 1979-1986

General Electric Erie, PA.

* Set up and operate various production machinery and inspect own

work.

* Sensitive drill press, Lathe, Vertical mill, Brake press,

Electronic heater, Thread mill, Broach machine, Radial drill

Fabricator, Assembler and Product Finisher 1986-1989

Ervite Corp. Erie, PA

* Set up and operate various production machinery and inspect own

work.

* Brake press, CNC punch machine (Amadas) Pem machines, Assembly

and painter in waterfall booth on production line.

Education

2012 ASME - PRACTICAL WELDING TECHNOLOGY

2011 ASME B31.1 TRAINING

2010 LEAN OPERATIONS CHAMPION TRAINING

2009 SIX SIGMA FOR PROBLEM SOLVING GREEN BELT TRAINING

2009 RAB QSA CERTIFIED LEAD AUDITOR ISO 9001:2008

2005 RAB QSA Certified Lead Auditor ISO 9001:2000 and ISO 13485:2003

(Medical device focus) AQS Management Systems, Inc.

2003 GMP/QS Requirements and Industry Practice (FDA Quality Systems

Regulation)

1998 ANSI-RAB Accredited Lead Assessor Course

1996 Measure Manager (CMM training)

1996 Symphony of manufacturing workshop

1995 Time Management

1995 ISO 9000 writing work instructions and procedures

1995 Dale Carnegie leadership course

1995 Computer- Windows, Excel,PowerPoint

1995 64 hours Supervisory Skills Course

1994 Auditor Training -Penn State Behrend

1988 Management Administration courses at Gannon University

1987 Effective Group Discussion - Gannon University

1979 General Electric Machinist Training

References :

Oshra Kelley, Esq.

Legal Counsel

Mobile phone: 1-814-***-****

Frederick Ebert

Procurement Manager

4725 Loop Road

Waterford, Pa 16441

814-***-****

Contact this candidate