Jack Chandler

Jack T. Chandler
978 5th Street SW 651-492-8782
New Brighton, MN 55112 jack_chandler@yahoo.com

QUALITY ENGINEER, ASQ – CQE, CQA, CBA
Bachelor of Electrical Engineering, University of Minnesota

Quality Engineer known for being a detailed quality system auditor, and for leading communication
with suppliers, purchasing, manufacturing, and design stake holders

QUALITY
ENGINEER

Analyzing data, SPC, DOE Auditing – internal & supplier
Creating policies/procedures
FMEA
Writing inspection procedures

QUALITY SYSTEM AUDITOR

FDA Part 820 QSR
ISO 9001
ISO 13485
ISO 14001

INCOMING MATERIAL REVIEW

Verification and disposition of rejected material
Coordinate with purchasing and manufacturing
Supplier Corrective Actions

COMPONENT
ENGINEER

Led coordination between design, manufacturing, purchasing, and suppliers
Qualifying components, and materials
Writing/changing component specifications

PROFESSIONAL EXPERIENCE

US Electronics Inc/Quality Engineer – 2014 to 2016
• Coordinated BSI ISO 9001 and 13485 Audits, and Health Canada Audit
• CAPA, Procedure Updates, Incoming Inspection

Contract Auditor/Supplier Quality Engineer – December 2012 to September 2014
• Internal Audits for local manufacturing company, and contract Supplier Quality Engineer

Boston Scientific/Guidant Corporation, Arden Hills, MN, 2000 – 2012
Supplier Quality Engineer
• Implantable components
• Quality approval for indirect suppliers including clean room suppliers, equipment, and calibration providers
• SCAR generation and follow up
• Conferred with suppliers, Manufacturing Engineers, and Incoming Inspectors to ensure quality product is received
• Coordinated measurements and observations with suppliers, manufacturing and design
• MRB Member – Resolve and disposition of non-conformance supplier materials
• Performed ISO 13485 based supplier audits with existing and potential suppliers, both US and OUS – current passport
• Created design drawings, and inspection procedures
• Prepared, coordinated, and led quality reviews with supplier partners
• Reviewer process validations

St. Croix Medical/Envoy Medical, Minneapolis, MN, 1997 – 2000
Component Engineer
• Selected and approved suppliers for implantable components and assemblies
• Coordinated with Design and Manufacturing Engineers to prepare component/assembly specifications used in implantable medical devices
• Prepared and executed qualification test plans
• Performed supplier audits per ISO 9001
• Outsourced failure analysis of components and assemblies

MEMBERSHIPS

American Society for Quality – Senior Member and Chair of Biomedical Consortium
North Central Chapter Electrostatic Discharge Association – Former Member and Past
President
Toastmasters International – Former Member

COMPUTER SKILLS

Microsoft Word
Excel
PowerPoint
Minitab

PROFESSIONAL CERTIFICATIONS

ASQ Certified:
Quality Auditor #30557, CQA
Biomedical Auditor #195, CBA
Quality Engineer #59796, CQE
Guidant/Boston Scientific:
Six Sigma/Green Belt Certified

Additional Info BACK TO TOP

Current Career Level: Experienced (Non-Manager)

Date of Availability: Within 2 weeks

Active Security Clearance: None

US Military Service: Yes

Citizenship: US citizen

Target Company: Company Size:

Target Locations: Relocate: No

Willingness to travel: Up to 25% travel

Languages: Languages Proficiency Level
English Fluent

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2016-11-04