Global Configuration Management Manager Resume

SUMMARY

Configuration and Data management practitioner with proficiency in control processes, software configuration, design configuration, R&T, IS design, document control, and project management in medical, aerospace manufacturing companies.
Excel in fast paced regulatory environments, delivering quality solutions that proactively address problems, improve configuration controls, product quality, manufacturing flow and customer satisfaction.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Confidential

Global Configuration Management Manager

Responsibilities:

Manage CM directives for all PLM enhancements/ongoing continuous improvement.
Manage CM efforts in creation and implementation of process plans and BOMs with document association in PLM/ERP systems.
Established and manage program management configuration controls.
Ownership of Configuration and Data Management requirements for all Commercial and Government programs throughout the Product Life-Cycle
Supervise PLM IT staff in creation/enhancement to system.
Facilitate the creation of all Business Management CM documents.
Interface with the Engineering, Quality, Production, Program Management, Contracts, Finance and Supply Chain in driving the definition, implementation and adoption of Configuration Management processes, policies and procedures.
Support New Product Introduction and production teams with Configuration procedures and training.
Established and maintain comprehensive document retention archive system across all enterprise locations
Oversee Configuration Control Boards and Functional/Physical Configuration Audits.
Supervise team of Configuration and/or Data Specialists

Confidential

Quality Supervisor

Responsibilities:

Coordinated site-wide training and training database management including development of a tracking chart posted in the manufacturing area.
Executed change control process (including obsolete document removal and replacement at point-of-use).
Maintained all device documentation, per prescribed retention periods, at site & 3rd-party (Iron Mountain) locations.
Supported QMS audits, including internal, customer, and regulatory compliance audits including 2 FDA inspections resulting in zero 483 items.
Coordinate Device History Record control (job pack creation to controlled configuration, review of completed records, and management of barcoded archive.
Supervise labeling department including implementation of improvements that resulted in elimination of label content defects.

Confidential

Equipment Manufacturer

Responsibilities:

Legal research, case management, stock option plan administration.
Preparation for annual audits, investigation and data assembly for regulatory investigations; internal matters, and international trade issues.
Supervised SEC defense of SEC insider trading allegation.
Supervised EPA defense.
Managed OFAC/SDNL compliance program.
Implemented contract and document management.
Maintained legal department budget in excess of 2 million annually.
Key role in overhaul of worldwide physical inventory.
Designed and implemented trademark and patent data management system.