Hanne Jensen Email & Phone Number

Achievements: • Achieved MDR- certificate for Zenith Alpha™ Thoracic Endovascular Graft Distal.• MDR documentation on Zenith® TX2 Dissection Endovascular Graft with Pro-Form® and Zenith Dissection Endovascular Stent) send to Notified body.• Devices/Products are in compliance with MDR. Responsibility:• Implementation of MDR (Medical Device Regulation) on Zenith Alpha™ Thoracic Endovascular Graft Distal Component (legacy product).• Implementing of MDR on Zenith® TX2 Dissection Endovascular Graft with Pro-Form® and Zenith Dissection Endovascular Stent.• Evaluation of "Complaint trending" for the purpose of updating documents and changing at Risk.• Data for the “Post Marked Surveillance Annual Report”.• Participate in BSI I audit.• Statements/rationales on:- existing tests can be applied to other products or - a designs change does not affect patient safety.

Achievements: • Implementation of material and/or process changes, without compromising on quality and the safety of the patient.Responsibility:• Internal Cross function management on materials/compositions/processes changes from supplier.• Solve NCR (non-conforming reports).• Supplier management.

Achievements: • Successful implementation of the first modular and optimized OK mill size.• Project plan for implementation remaining mill sizes.• Internal leaflet with main information and a conversion table on the Ok mill.Responsibility: • Status reporting to management on strategic projects. • Problem solving of mechanical, manufacturing and quality problems.• Implementation of an optimized version and a modified type range of a product.

Achievements: • Weight reduction / manufacturing improvements / efficiency improvements, resulted in a saving of 71 m DKK. • Strong cooperation between the product specialist, Purchasing, supplier and management.• Common Project Model and a "generic" project plan in Microsoft Project.Responsibility: • Project manager on Value Engineering with a budget of 10 m DKK and a goal of an enablement/savings of 50 m DKK.• Report to management on progress and results. • Processes to support interdisciplinary collaboration. • Establishment of a project model for small and large development projects.• Support, guide and follow up on projects with Project Managers from other departments.

Achievements: • On-time delivery, cost reduction on handling time / reduced lead time.• Successful implementation.• Improved product quality.• 2 x Spot bonus:"For her persistent and extraordinary efforts in the CAPA area. Including being the driving and follow-up force in terms of solving and eliminating all the reported NCRs, some of these with 'Root cause analysis'. In this area, Hanne is a role model for others in an effort to raise the quality of FLSmidth's deliveries, and thus also the company's public face towards customers." "To always responsibly take prompt action, deliver fast and qualified responses to our colleagues in the organization, as well as an excellent effort in the CAPA/NCR area."Responsibility: • Planning and implementing a new optimized version of a product. • Root Cause Analyses on errors.

Achievements: • A Safety Risk Assessment (SRA) template, meeting request plan, and master plan to execute risk assessments on all the main machines and associated documents.• Quality improvement in the organization.• Introduced processes and procedures to align products/machines across departments.• 2 x Spot bonus:"Hanne has delivered a remarkable effort by arranging the demanding task of updating the risk assessment for one of our main machines, the OK cement vertical mill. In a long haul and through a large number of meetings with specialists on the machine and on safety, all questions are thoroughly worked out. This has paved the way for continuous work to update the risk assessments on our machines and put together a complete package of the necessary safety documents.""Hanne is recommended for anchoring in the organization through the group of quality officers and the ongoing work of handling reported errors and deviations. The efforts in the quality projects take place at the same time as a continuous and persistent work to raise the level of risk assessments and safety documentation for our machines. Here, an independent and competent effort is delivered in a project that receives far less attention than justified. Overall, the effort is extremely valuable in maintaining and implementing a real quality-improving effort in the organization, which is why Hanne is recommended for a spot bonus award."Responsibility:• Facilities and coordinate updating of the risk assessments of the main machines.• Co-project manager on a quality improvement project.

Achievements: • Short "delivery time" and a reduced hourly consumption.• Achieved alignment and a better quality."Your manager has justified the attitude with your commitment and initiative in the work with the FQR system, where you on your own initiative have cleared and closed a large backlog of unfinished FQR*s and in general have worked disciplined and contributed to raising the quality level."Responsibility: • LEAN on order/project start.• Process errors.• Processes and procedure for order management of products.• Ensure knowledge sharing with our Indian colleagues.• Outsourcing of order handling.

Achievements: • Developed and implemented a uniform order management procedure.• Increased productivity and on-time deliveries due to a structured and clearly defined responsibility.• Only one supplier, larger purchase discounts less waste.Responsibility:• Order fulfillment, GA drawings.• Purchasing of Lubrication for first time filling. (For a Cement plant).• Customer meetings.• Lubricant conversion table (between lubricant brands).

Achievements: • An improved product and an optimized production due to the implementation of ribs and a black surface, on the transport trays.Responsibility:• Project manager on a development/optimization project of a freeze-drying plant for Instance coffee (CONRAD).

Achievements: • Improved product and process.• Compliance with the Machinery Directive.• Quality improvement.• CE-marked product.Responsibility:• CE marking of machinery.• Product management and Project management.• Internal auditor in ISO 9001.

Achievements: • Increased spare part sales.• Satisfied customers who ordered more spare parts and invested in new plants or upgrades.Responsibility:• Spare parts offer for complete plants. • Order handling.• Agency responsible.