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Quality Manager Engineer

Location:
Erie, PA
Posted:
September 11, 2022

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Resume:

Tracy Darlene Sandell

***** **** ***** ****, ***********, Pennsylvania 16404

Home 814-***-****, Mobile 814-***-****

Tsandell_avon@yahoo,com

Dear Sir/Madam,

Please consider the enclosed resume as an expressed interest in joining your company in a capacity that will most effectively utilize my education, skills and experience.

I have over twenty-five years of experience with progressive responsibility in Management, Quality, and Continuous Improvement. I am a team player who welcomes change. I am a Certified Lean Six Sigma Master Black Belt (CLSSMBB), and have been awarded the opportunity to apply these skills throughout my career. I have achieved a Bachelor degree in Business administration, and an MBA through Ashford University. I have passed the Certified Quality Engineer exam (CQE) and the Certified Manager of Quality/Organizational Excellence exam (CMQ/OE) through the American Society for Quality, and I have extensive experience with quality systems such as ISO9001, AS9100, ISO13485, EN13980, IRIS, cGMP and IATF16949, along with several regulatory agencies and environmental compliance regulations such as FDA, RoHS, REACH and ATEX. With my strong leadership skills, commitment to achieving corporate and strategic goals, and strong communication skills, I feel I would be an asset to your organization.

I am looking forward to discussing this opportunity with you in further detail. I can be reached at 814-***-****. Thank you for your time and consideration.

Sincerely,

Tracy D. Sandell

Enc.: Resume

Tracy Darlene Sandell

17297 Post Ridge RD, Centerville, PA 16404 Telephone 814-***-****, 814-***-**** (cell)

Education

Villanova University

Certified Advanced Lean Six Sigma Master Black Belt

Certified August 2014

Ashford University

MBA in Business Administration/Specialization in Global Management

Graduated June, 2013; GPA 4.0

BA in Business Administration/Specialization in Operations Management

Graduated April, 2012; GPA 3.89

American Society for Quality

Certified Manager of Quality/Organizational Excellence-2007

Certified Quality Engineer-2000

Certified Lead Auditor for:

IATF16949, AS9100, ISO13485, ISO9001

Experience

PTR Tool and Plastics-Currently employed

Quality Assurance Manager–Currently employed

Implement and maintain IATF16949 automotive standard

Lead and facilitate all Continuous Improvement initiatives and Six Sigma projects

Direct bottom line continuous improvements of +$65K

Performed 8D training for all quality and management staff

Direct reports include Quality Manager and Quality Engineers

Also responsible for EHS, all training and some HR functions

Associated Spring

Quality Assurance Manager

Implement and maintain IATF16949 automotive standard

Lead and facilitate all Continuous Improvement initiatives and Six Sigma projects

Direct bottom line continuous improvements of +$425K

Performed 8D training for all quality and supervisory staff

Direct reports include Quality Technicians and Document Coordinator

FXI

Quality Manager/Safety Manager

Implement ISO9001 compliant quality system. Perform internal audits; manage audit schedule, procedure writing and companywide training of the quality system.

Lead and facilitate all Continuous Improvement initiatives and Six Sigma projects

Direct bottom line continuous improvements of +$200K

Supplier selection and development

Direct reports include lab technicians

Train on the use of problem-solving tools, internal auditing and QMS compliance.

Oversee the handling of customer complaints, internal and external CAPA process

Also responsible for EHS program

Tech Molded Plastics

Director of Quality

Establish and monitor all Key Process Indicators as part of the management system review

Implement TS16949 quality system. Perform internal audits; manage audit schedule, procedure writing and companywide training of the quality system.

Lead and facilitate all Continuous Improvement initiatives and Six Sigma projects with direct bottom line improvements

Supplier selection and development

Direct reports include quality manager and management representative

Train on the use of Core Tools and QMS auditing and compliance

Oversee the handling of customer complaints, internal and external CAPA process

Essentra Components

Quality Assurance Manager

Establish and monitor all Key Process Indicators as part of the management system review

Maintain TS16949 quality system, including companywide training of the quality system.

Responsibility for the maintenance of QMS in Two International Manufacturing Facilities, 16 Warehouse and all express and distribution sites across north and south America.

Supplier selection and development

Direct reports include quality engineers and quality technicians

Train on the use of problem-solving tools such as 6 Sigma and 8D, train on internal auditing and QMS compliance.

Oversee the handling of customer complaints, internal and external CAPA process

PowerDrives

Corporate Quality Manager

Maintain TS16949 quality system. Perform internal audits; manage audit schedule, procedure writing and companywide training of the quality system.

Responsible for the maintenance of quality management systems in Three International Facilities.

Direct reports include plant level quality managers, quality engineers and quality technicians

Train on the use of problem-solving tools such as 6 Sigma and 8D and 7-step, train on internal auditing and QMS compliance.

Oversee the handling of customer complaints and all internal and external CAPA process

Matric Limited

Director of Quality Assurance –2008 to 2012 (ISO 9001, ISO 13485, AS9100, EN13980 Certified)

Establish, monitor and measure Key Process Indicators as part of the management review system

Implement and maintain ISO 9001-2008, AS9100 and ISO 13485 quality systems. Implement and maintain ITAR compliance program. Maintain EN13980, RoHS certifications. Perform internal audits; manage audit schedule, procedure writing and companywide training of the quality system.

Responsible for the implementation and maintenance of quality management systems in Three Facilities.

Lead CI process improvements with direct bottom line improvements totaling +$4M

Manage quality engineers, quality analysts and quality supervisors in Seneca and Pittsburgh facilities

Train on the use of problem-solving tools such as 6 Sigma and 8D, train on internal auditing, ITAR and QMS compliance.

Oversee the handling of customer complaints throughout the initiation, investigation, root cause analysis, corrective action, response to customer, and follow up.

Supplier selection and development

Design and analyzed DOE’s.

References available upon request.



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