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Supplier Quality Engineering Manager

Principal Supplier Quality Engineer

Siemens Ultrasound

Oversee all aspects of the global audit program, which is compliant to Medical Device Single Audit Program (MDSAP).  Serve as primary interface with external regulatory bodies. Lead large scale QMS activities such as Legal Manufacturer’s address change and manufacturing plant relocations. Identify and implement changes to all domestic and international sites to maintain regulatory compliance. Train and mentor internal auditors.

Global Audit Manager

Arthrex

Managed the strategy and implementation of all aspects of the site quality function, including internal and supplier process validations, receiving inspection, and validation of supplier verified inspections. Responsible for developing, tracking and initiating corrective and preventive actions to address customer complaints, internal and supplier nonconformances, throughput improvements, nonconforming materials management, and material identification and traceability.

Quality Assurance Manager

Welch Allyn

Manage the system and resources to validate quality goods and services are routinely received at Welch Allyn.  Global Audit Manager to oversee the Internal Audit program to ongoing compliance to all standards and regulations. Updated and validated the Complaint and CAPA systems including a global system redesign and implementation.  Managed complaint system daily operations including staffing, data management, and trend reporting to product managers.

Global Supplier Quality Manager

Topflight Corporation

Designed, executed, and validated processed and equipment to ensure meeting customer requirements and provide manufacturing flexibility between equipment groups.  Integrated large scale incremental business into current systems, assuring robust processes and products.  

Oversaw the transition to ISO 9000:2000.  Recommended, managed, and executed capital expenditures to improve data collection, analysis, and manufacturing throughput from equipment specification and design through procedure generation, operator training, and validation.

Set corporate direction as a key member of the strategic development and implementation team.  Implemented significant upgrades to quality systems including a new document control system, major revisions to the corrective action system, implementation of a new validation and design control system.

Quality Management, Quality Engineer, Product Development Engineer

LifeScan, a Johnson and Johnson Company

Multiple

Fifteen plus years of professional responsibilities in audit management, supplier management, engineering, and production. Experienced Class II and III medical device industry experience, supporting all aspects of Quality Management System activities. Master’s degree in Engineering and Global Operations Management complimenting a bachelor’s degree in Physiology.

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