Daniel Kramlinger Email & Phone Number

Woodbury, Minnesota

• Successfully implemented an electronic document control database using the uniPoint Quality software for the facilitation of document change orders, revision control, distribution, and retrieval.• Successfully implemented an electronic database training system using the uniPoint Quality software to maintain employee training and occupation records, skills matrix, and company wide gap analysis tracking for missing and recurring training needs.• Assisted in achieving AS9100 certification through a two stage audit process as well as ISO9001 recertification.• Assist in the coordination of ISO14001 Environmental Management System (EMS) objectives.• Facilitator/Lead of Continuous Improvement Teams including Lean Manufacturing and Enhanced Learning Programs.• Project manager for Performance Improvement Teams and systemic Corrective Actions.• Process NAFTA certifications as well as environmental declarations such as Prop65, RoHS, and REACH.• Author of quality system documentation releases and revisions including policies, procedures, work instructions, forms, and flowcharts.• Hold the roles of Training Coordinator and Document Control Administrator.

Saint Paul, Minnesota

• Document and generate Detailed Supplier Quality Performance reports for inspected shipments along with charting quarterly and annual quality summary results. • Work with suppliers to troubleshoot and resolve quality issues identified at inspection. • Established a new customer complaint system for the tracking and trending of customer identified issues. • Perform First Article Inspections for new incoming products and generate the subsequent report to communicate back to suppliers. • Working to establish an updated document control process to better control the approval, distribution, and retrieval of documents. • Creating product specifications for new and legacy products.

Woodbury, Mn

• Book and schedule production jobs for incoming customer purchase orders using the Epicore Vantage ERP system. • Contract review new purchase orders against the most up to date quotes and customer agreements to ensure completeness and accuracy. • Print and prepare job card packets. • Review previous job cards from a process engineering perspective and update part file masters when required. • Process booking adjustments as appropriate. • Generate and analyze reports against daily and monthly bookings, adjustments, sales orders/no jobs, and other reports generated from the Vantage system. • Use of the Unipoint quality system database for verification of inspection data.

Greater Minneapolis-St. Paul Area

• Assisted in the launch efforts for Agile PLM software including process development, establishing a training program, and defining initial configuration• Configuration analyst for functionality, layout, and securities of Agile PLM software• Testing, validating, and documenting of changes and corrections to Agile PLM system configuration including patches and bug fixes• Support for end users and change analysts; Assist with training and troubleshooting activities• User Administrator for managing 4,000+ user accounts• Part of the integration team for implementing integration amongst Agile PLM and Oracle ERP software• Management of system OQ, PQ and UAT validation activities

Greater Minneapolis-St. Paul Area

•Participate in engineering project teams to support the generation and processing of change orders•Usage of Oracle R12 database for part maintenance and BOM construction activities•Record keeping including the maintenance of Device Master Records•Coordination of change implementations amongst various departments and global sites•Member of the project team to implement Agile PLM with varied duties including testing, writing SOPs, and training

Greater Minneapolis-St. Paul Area

• System administrator for Agile Advantage PLM electronic document database• Process change orders, CAPAs, deviations, and return records to ensure compliance• Utilize certified training to lead internal audits that ensure compliance to ISO 13485 and CFR 21• Provide assistance to Regulatory Affairs for the preparation of submissions to notified bodies• Review all manufacturing travelers for completeness and accuracy• Coordinate training for newly released procedures• Utilize Epicor Vantage ERP database for order entry and maintenance to the device history record• Maintain Device Master Records• Training Coordinator• Minor Solidworks experience

Greater Minneapolis-St. Paul Area

• Process engineering change orders relating to new or revised internal documentation• Control of document distribution• Coordinate the release and closure of deviations to standard practice• Maintain electronic database and hard copy systems for documentation including past archives• Process training records and maintain the Access training database system• Assist the director of quality in customer and regulatory audits• Utilize Visual Manufacturing ERP software for part maintenance and engineering master details, including bill of materials• Facilitated the merger of two documentation systems after the Medamicus acquisition of Biomec Cardiovascular united the companies as Enpath Medical (now Greatbatch Medical)

Greater Minneapolis-St. Paul Area

• Represent the front line of CPC by providing customer support relating to product information and assistance• Facilitate the generation of new leads; Interact with distributors and sales management to maintain accounts• Process purchase orders and returns• Partner with internal staff to research problems and satisfy customer requests• Utilize SAP Business Suite and Selltis Sales Community software on a daily basis

Wausau, Wisconsin Area

• Correspond with lab management• Train staff and keep them informed• Monitor employee time cards and log disciplinary actions when appropriate• Troubleshoot computer and printer hardware problems• Maintain supplies within the lab and assist users with questions relating to Microsoft Office, Internet Explorer, and other lab software