PROFESSIONAL PROFILE:

An experienced business minded P rofessional . Responsible to drive results and provide leadership to critical quality and regulatory activities including project implementation, team leadership, strategic planning, and records documentation. Highly developed organizational skills, accustomed to maintaining high productivity levels within the operations in support of overall corporate strategies and goals.

EXPERTISE:

Project Management ISO 13485 Team Management Financial ROI Process Improvements Implementation Planning Business Analysis

PROFESSIONAL EXPERIENCE:

Confidential, Brooklyn Park, MN

Program Manager, Quality and Regulatory

Responsibilities:

• Meet with cross - functional project managers and team members to drive deliverable completion or remediate issues to maintain project schedule.
• Manage multiple cross-funtional, global work streams to create Compliant SOPs and work instructions
• Create program governance and RACI documentation to ensure alignment of resources and processes
• Actively seek collaboration and build relationships with internal customers and external partners to improve overall outcomes and timely project completion.
• Create detailed complaint handling business process flows
• Create and maintain project definition documents, project schedules, report status and escalate issues to Steering Committee and all project Sponsors.
• Build team ownership and commitment to project and business plans and define project milestones and resource requirements.
• Collaborate with business users, internal technology teams across Olympus and vendors to establish and prioritize business and technology requirements

Confidential, St. Paul, MN

Manager, Document & Records Management

Responsibilities:

• Maintain efficiencies through leading metrics and KPI’s
• Manage the health of Engineering Change order process
• Maintain quality system documentation
• Reduce Engineering Change Orders resulting in the reduction of over 80 orders and a lead-time of over 30 days to zero days lead-time
• Provide leadership for Engineering Product Release system and document control resources of multi-million dollar medical services business
• Update document management and configuration management processes to align with ISO 13485 standards, FDA and other regulatory bodies.
• Audit records and document management processes for gaps against regulatory bodies.
• Analyze the feasibility of, and develop requirements for, business processes focusing on the effective use of resources or new systems and enhancements to existing systems from a business and technology perspective to ensure the design or change fits the needs of the business.
• Manage a team of document control specialists and records coordinators
• Develop a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery and cost.

Confidential, Mounds View, MN

Quality Applications Team Lead

Responsibilities:

• Provide document control oversight for a team of five Configuration Management Administrators and external contract resources
• Prepare site metrics and KPI’s, tracking avoidable rework and changes
• Create efficiencies by developing new processes for product release handling across global sites
• Project Manager to migrate data from legacy systems to Agile Engineering Change Order and quality management system.
• Perform testing support during Agile PLM upgrades
• Develop and managing budgets for projects including resource loading, external expenses and capital requirements
• Own project planning and management responsibilities for all assigned projects. Includes development of a project charter, project plan, schedules

Principal Supply Chain Project Analyst

Confidential

Responsibilities:

• Create detailed requirements for fully exploded Bill of Material Report between SAP and JD Edwards. Work it Global IT to create data warehouse to run ad hoc reports for product launche
• Manage multiple enterprise wide projects for Sourcing Organization including Risk management automation, financial reporting projects, and Global Sourcing Web resource and document management.
• Lead SAP division representative for conversion from JD Edwards ERP to SAP MM for procure-to-pay processes; coordinate requirements and testing.
• Participate on project teams as Global Sourcing liaison with IT;
• Manage detailed requirements gathering sessions with end users
• Participate in Kaizen events to create Global Sourcing Risk Management SharePoint site.

Business System Analyst

Confidential

Responsibilities:

• Gather business requirements for reporting needs for Enterprise Data warehouse.
• Document requirements and communicate reporting requirements.
• Liaison between Global Sourcing Department and IT technical staff.
• Partner with internal IT to create detailed reports combining SAP MM and JD Edwards information in support of product launches and on-going inventory and sourcing management.

Confidential, Brooklyn Park, MN

Business Analyst/Project Manager

Responsibilities:

• Project Lead and Technical Analyst for Plateau learning management system. Successfully negotiated Statement of Work, created project budget, work resources, schedules and timelines. Communicate project status to all project stakeholders and sponsors. Maintained detailed project cost tracking.
• Project lead for transition of applications to former corporate headquarters. Participated in knowledge transfer sessions under difficult situations due to corporate right-sizing exercise.
• Provide project management leadership to enterprise wide cross-functional teams and documentation to teams for system implementation for LIMS and Trackwise Quality Systems. Track to detailed project budget and project plans. Manage outside vendors and consulting partners. Create and maintain schedules, cost estimates, communication plans, and issue resolution plans. Manage project deliverables. Coordinate project progress. Conduct project status meetings and assist with implementation. Document business, technical, functional and regulatory requirements.
• Implement workflows in Trackwise and conduct training sessions for physicians and clinical personnel on use of Clinical Deviation tracking. Create workflows for Change Control processing within Trackwise.
• Communicate roles and responsibilities to team members utilizing a detailed matrix of cross-functional responsibilities. Indirectly supervise project team members. Participate in the yearly review process.

Confidential, Bloomington, MN

Application Systems Analyst

Responsibilities:

• IT Project Lead for implementation of 200+ person Sales Force Automation System (CRM system). Developed RFP, negotiate Statement of Work, Create project schedules, timelines, project plans, and communication plans.
• Liaison between business customers and IT technical staff. Successfully installed, configured and implemented software utilizing Windows Mobile Pro handheld devices and three-tier application.
• Provided training to over 200 Sales force professionals. Created training documentation and conducted training sessions.
• Successfully implemented Medicaid Claims processing system, functioning as IT Project Manager.
• Created RFP documents, participated on vendor selection team. Created project schedules, project plans, timelines, cost estimates.
• Configured system according to end user requirements. Interfaced system with EDI translation software and Great Plains Accounting.
• Participated on validation team to test software and ensure free from defects.
• Trained end users on use of system.
• Defined and implemented Network Infrastructure qualification plans.
• Develop and document system test plans and test cases for application validation.