Shawn Kloha - Mba, Pmp, Csm Email & Phone Number

United States

Remote

Manage complex enterprise software implementations for strategic customers in both High Tech and Life Science industries. Responsible for all customer facing activities (commercial and project related) as well as internal alignment between project teams and product teams.

Manage complex enterprise software implementations for strategic customers in both High Tech and Life Science industries. Responsible for all customer facing activities (commercial and project related) as well as internal alignment between project teams and product teams.

Kalamazoo, Michigan Area

Managed the multi-site roll-out of the Revenue Management application Model N, which handles such processes as cross-divisional rebating, membership, capital contracts, FSS, and reporting. Responsible for coordinating multiple system integrations, including multiple ERPs (PRMS and Oracle 11i), BI, and SalesForce.com. Led a large and complex team consisting.

Kalamazoo, Michigan Area

As a Project Manager, I led the planning and multinational roll-out of a robust and scalable labeling system with multiple ERP integrations for a large division to ensure UDI, quality, and global regulatory compliance. This included creating and executing a deployment playbook, organizing all phases of the SDLC, planning system integrations, partnering.

Kalamazoo, Michigan Area

As a RAQA Business Analyst, I successfully managed multiple IT projects as acting project manager in part of a larger Merger and Acquisition program. These projects included the following software:o Oracle Enterprise Asset Management (eAM)o CompuCal calibration tracking software o PEMAC maintenance tracking softwareo Component verification softwareI led.

As a Quality System Project Specialist for Stryker, I was mainly in charge of ensuring the QMS at my site was effective and compliant. Some of my duties included managing the corrective/preventive action process, administering the Quality System including documentation and system registration status, performing internal QS audits and training auditors.

As a Regulatory Affairs Quality Assurance Representative, I helped to maintain the quality and regulatory compliance of my site. Some of my tasks included:- Managing the complaint handling process and MDR filings- Assist in developing documents to submit to FDA: Premarket notifications (510(k)), Premarket Applications (PMA) – original or supplements.

Greater Grand Rapids, Michigan Area

One of the main reasons I was brought on as a Quality Systems Coordinator at Vi-Chem was to support the initial TS 16949 certification audit for this company. This included ensuring that the Quality Management System was up to the proper requirements, performing internal audits, assisting in the pre-assessment audits, participating in the assessment audit.

Being a Co-Manager at 84 Lumber was an interesting role. I was first and foremost responsible for taking care of the customer when they came in the store. This included greeting, providing assistance locating materials, loading any materials that they purchase (lumber, trim, concrete, etc), and ringing them up. Additionally, I was able to help them plan.

Responsibilities included inventory, payroll, food preparation, scheduling, hiring and firing, customer service.

High School Co-op working in the C.A.S.T. group.

Masters, Business Administration

MBA

Bachelors Of Science, Industrial Management

Activities and Societies: Sigma Pi Fraternity