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