David Marek Email & Phone Number

Boulder,Co

UDI Product Data Management: Develops business requirements for Product Master Data Management, data quality standards and Data Governance as required to achieve UDI compliance.Completes strategic planning for PMDM design and implementation to support UDI compliance and business process across the global business units and for acquired companies.This includes assessing the current state for data collection, providing data source interface requirements,and collaboration with the various functional business stakeholders as to UDI implementation requirements.

Boulder,Co.

Leads the Document Control organization comprised of Document Control Management representatives across all business units globally. Reviews, manages and reports on global document control activities and improvements to senior leadership. Leads PLM integration and deployment projects related to business process improvements and acquisitions for quality systems. Manages all Document Control personnel and associated department budget. Assures compliance to 21CFR Part 820, ISO13485 and applicable company quality systems requirements for control of documents, records management, NCR ‘s and quality system training.

Collaborates with senior management to bridge the gap between project objectives and resource allocation, while leading improvement projects for key configuration management processes and deliverables across the division and globallyLead business process improvement projects to harmonize engineering documentation change control systems / change control process design between Santa Rosa California, Galway Ireland, and Danvers MassachusettsProvides leadership as a steering committee member for SAP/PDM system site deployment and master data requirements for document control change system (BOM, SAP item master, Agile PDM)Provided solutions for impacted business process, BOM structure, SAP material master data, and Agile PDM system change process for manufacturing /operations Assessed the current configuration management-related processes to determine the degree to which those processes conform to configuration management best practices