Manager Quality
Resume:
Andrea S. Feidler
**** ***** ****** ****, ************ 16511 Home 814-
Email: *******************@*****.***
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
Contact this candidate