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Quality Engineer

Location:
Novi, MI
Posted:
April 12, 2018

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Resume:

Tammy Tuttle

PO Box ** Wolf Lake, IN ***** 260-***-**** ************@*****.***

Profile:

Quality professional with proven performance in implementing quality systems, sample analysis, report writing, regulatory

compliance, and maintaining controlled documents.

Skills:

• CAPA Lean Manufacturing

• Process Improvement Training program implementation

• Kaisen Events PPAP

• Creative Problem Solving Microsoft Office

• Expertise in troubleshooting issues Mini Tab

• Team player SPC

• Quality control TS 16949 Internal Auditor

• Certified Trainer ISO 9001 Internal Auditor

• Total Quality Management (TQM) ISO 14001 Internal Auditor

Accomplishments:

Quality Improvement

Implemented an electronic supplier database and significantly reduced error and manpower for Supplier Corrective

Action.

Presentations

Created presentation materials for supplier quality – sourcing relations and management purposes to review the

investigations and issues for potential CAPA cases as well as facilitating the progression of CAPA cases to closure.

Training

Supervised and trained all employee’s on TS/ISO Quality Systems

Organized and delegated projects for new hires and according to co-workers abilities

Quality Control

Identified and recommended process improvements resulting in $1MM annual cost savings by having pre-printed tags.

Implemented with Kaisen Group Vision System on production line for accepting and/or rejecting product. This has

made customer mandated inspection accurate and efficient.

Customer Interface

Met with customers to resolve corrective actions, to get support teams at their facility when needed, to help resolve all

issues.

Product Improvement

Liased with Supplier Quality Team to modify and improve overall product performance of the Receiving Inspection

Department.

Recommend to implement electronic gaging. This implementation has increased the amount of inspections by 78% and

has decreased human error by 88% within the first month of implementation.

Professional Experience:

Northern Indiana Manufacturing

January 2013 – June 2013

202 S. Ecker Ave

Bourbon, IN 46504

574-***-****

Quality Manager

Responsible for the overall achievement and maintenance of the Quality System (ISO9001 certifications) for

corporate. Supervise 3 direct reports.

Developed QA procedures and established quality assurance methodologies/standards in order to clarify the quality objectives of

the organization.

Initiated an evaluation procedure which led to the redesign of major processes, and implementation of new policies, resulting in

an increase of efficiency and reduction in personnel expenses.

Increased efficiency 18% by implementing a Kanban system and changing the shop layout to promote ease of movement and

decrease clutter.

Initiated an evaluation procedure which led to the redesign of major processes, and implementation of new policies, resulting in

an increase of efficiency and reduction in personnel expenses.

Acted as a focal point and leader to all quality related programs – Directed QA activities to ensure maximum quality and

effectiveness

Managed production of quality reviews including selection, execution and reporting.

Responsible for measurable’s for quarterly management review.

Performed internal QA audits that are in compliance with corporate policies, practices, and procedures.

Responsible for completion and all aspects of the PPAP process.

Promoted and advocate quality Achievement and Performance Improvement along with Continual Improvement programs across

the organization.

Cequent

September 2012 – December 2012

2602 College Avenue

Goshen, IN 46528

574-***-****

Corporate Quality Systems Coordinator

Responsible for the achievement and maintenance of the Quality System (ISO9001/ TS16949 certifications) for the

organization

Assist in the development of launch related timelines, gate books, and other customer specific launch related documentation.

Assist in internal audit and maintenance of ISO 14001

Complete all aspects of the PPAP process

Responsible for measureable’s for monthly management review

Monitor customer supplied warranty data and supplier PPAP files.

Responsible for monitoring and maintaining internal and external corrective actions

Primary interface for customer quality communications

Responsible for control of internal and external Quality System documentation to include Quality System manual, procedures,

work instructions, forms, etc.

Perform periodic audits; analyze data obtained for evidence of deficiencies in controls, duplication of effort, extravagance, fraud,

or lack of compliance with standards, procedures and management policies.

Worked with Continuous Improvement Teams and Corrective Action Teams on team processes and documentation.

Worked with all departments and managers to ensure that Quality System documents are updated as described in the Quality

System and are current and available in compliance to ISO/ TS standards.

Performed training (as appropriate) to enhance and improve overall company knowledge of the Quality System.

Zimmer

March 2011 – September 2012

508 N. Detroit Street

Warsaw, IN 46580

574-***-****

Supplier Quality Engineer

Responsible for the overall management of the CAPA/ZSCAR system. Supervise 2 direct reports.

Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality

management system, FDA Compliant, and ISO 13485.

Responsible for monitoring and maintaining compliance with the CAPA procedures, provide information and lead CAPA

Reviews, as well as track metrics for the sites Management Review Meetings.

Coordinated Root Cause investigations of issues for potential CAPA cases as well as facilitating the progression of CAPA cases to

closure.

Revamped CAPA log to ensure correct and accurate problem description and recording

Interface with Engineering and Buyers to ensure transfer to Production of new products are in accordance with approved data

Ensure timely resolution of supplier failure, corrective actions and preventive actions.

Responsible for Approved Supplier List for the following: All Warsaw Facilities, Shannon, Ireland and Austin, Texas

Establish item-supplier relationships

Update Supplier Status Changes

Trained full time personnel on PPAP documents (FMEA’s, Control Plans, Process Flows)

Implemented 8D format and revised CAPA/ZSCAR Process

Organize and conduct monthly Sourcing/Supplier Communication Meetings

Busche Enterprises

June 2004- January 2010

Albion, IN 46796

Quality Systems Administrator

Responsible for the overall management of the quality system for eight facilities, internal audit process, corrective

action process, and management review process. Supervised 1 direct report.

Developed comprehensive management system based on processes resulting in 3 rd party registration to TS16949/ISO9001 with

zero non-conformances.

Expanded document change control to organization change management process

Monitor production performance and facilitate groups to identify and correct performance not to target.

Developed Supplier Audit Program

Monitor all approved suppliers and audit suppliers according to schedule

Provided in depth and comprehensive understanding of processes, their interrelationships and effect resulting in improved and

organizational performance

Implemented “GATES” for a more robust PPAP system

Created and Implemented C.H.I.P.S Program

Developed electronic process layered audit program

Medtronic

March 2003- May 2004

Warsaw, Indiana

Supplier Quality Engineer

Responsible for the overall management and monitoring of suppliers for medical industry.

Implemented an electronic supplier database and monitoring ISO 13485 system

Responsible for gage correlations for all suppliers

Nacam North America

July 2000 – Ocotober 2002

Hebron, Kentucky

Quality Engineer

Responsible for the overall management of the customer relations for Ford and Chrysler products and the quality of the

product during the manufacturing process. Supervise 3 direct reports.

Developed comprehensive management system resulting in 3 rd party registration to ISO 14001 with zero non-conformances.

Implemented environmental audit program

Responsible for corrective actions

Responsible for reporting supplier score cards on a quarterly basis

Identified and Implemented process improvements resulting in $10K annual cost savings.

Fort Wayne Anodizing

March 1998 – July 2000

Fort Wayne, Indiana

Quality Manager

Responsible for the overall management of the quality department and the chemical solutions. Supervise 1

direct report.

Implemented quality management system and achieved ISO 9001:2000 registration with zero non-conformances within 6

months.

Handled all communication with customers

Conducted all internal audits

Responsible for all key measureables and reporting in management review.

Responsible for conducting all chemical analysis

Education and Training

Harrison College

Bachelor of Science in Business – 2013

Indiana Business College

Associate of Science in Business – 2003

Certified TS16949 Internal Auditor – 2006

Certified ISO 9001Internal Auditor – 2004

Certified ISO 13485 Internal Auditor -2004

Certified ISO 14001 Internal Auditor – 2002

Yellow Belt Certified – 2009

Affiliates:

American Society of Quality (ASQ)



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