William Erdmann Email & Phone Number

Medical Device product development consultant. Project is to remain confidential

Responsibility for four departments:Quality Operations. (day-to-day product quality and disposition of arterial access sheaths, guidewires, femoral and radial class-III closure devices)Supplier Quality Department (~ 200 vendors)Responsible for the Incoming Inspection Laboratory, and DHR review sectionResponsible for Calibration and MetrologyRemediated an.

Managed the decommissioning of two contact lens manufacturing plants for Bausch & Lomb: B&L, Rancho Cucamonga, CA and Unilens, Clearwater, FLClosed-down the quality systemRevoked the certificates for the plantArchived all design history records and files and device master recordsIntegrated the production schedule to the Clearwater plant in Florida

Responsible for managing product support teams in an FDA 483 warning letter remediation effortSet up a statistics department and directed the review of statistical rationale of all in-process inspection SOP’s with respect to the 510K & package insert claimsReviewed and updated the risk management files according to ISO14971 for each IVD product with the.

Responsible for establishing a worldwide Design for Six Sigma (DFSS) product development system that promoted robust design, and enhanced product innovation of Becton Dickinson. Program sponsored by the BD executive team.Directed DFSS program implementation for all mission critical medical device development programs worldwideEmbedded robust design.

Responsible for implementing Six Sigma in BD’s worldwide operations Managed the implementation of the Six Sigma philosophy company wideTrained and deployed 300 Black Belts and 200 Green BeltsReduced manufacturing cost by more than $50,000,000 worldwide

Process design changes that produced $4.5M annually in yield improvement of a chemical process. Received the Polaroid Presidential Quality awardSupervised a three-shift quality control lab for polaroid SX-70 integral film manufacturing

Supervised a three-shift chemical reagent plantSupervised the incoming inspection analytical laboratory