Edwin Roberts Email & Phone Number

Windfall, In

Online FMEA Training program

Indianapolis, In

• Participant in a DHF Remediation, review computer system files and folders for DFMEA, PFMEA, and other associated documents• Create "GAP" documents for each difference in the documents. • Write GAP closure documents. • CAPA team member, determine root cause, write reports.

Drove change into the supply base reducing internal costs. • As a Six Sigma Project, created a Cost of Quality monthly report that found a potential $1.6 Million in annual savings. • Taught classes and mentored quality team members in CQA, CQI, and CQT. • Developed quality metrics that tracked process defects and improved outgoing systems, • Established departmental and individual goals, • Supervised 16 employees.

Coordinated and managed the returned material center and implemented process improvements.• Performed failure investigations on returned goods; wrote and filed Medical Device Reports (FDA 3500) with the FDA. • Tracked product defects and published statistics to internal and Asian sources. • Participated in DFMEA programs on new products. • Trained and managed 10 quality inspectors, • Managed special Projects and off site third party rework.

Managed incoming product quality valued at $450 Million per year.• Reconciled quality issues in two metal stamping plants by driving root cause investigations via the 8D, and Red X protocol as well as reviewing, resolving, and ensuring that corrective action plans were implemented.• Drove corrective actions into the supplier’s supply base.

Mba

Bachelor Of Arts, Biological And Physical Science

Chemistry Major