Danielle A. Email & Phone Number

Albany, New York Metropolitan Area

Spencer, Indiana, United States

Managed product project portfolio, aligning project prioritization, resourcing, and financial planning with divisional and operations teams– Managed several projects for the LithoVue Elite (LVE) Trident program, coordinating design reviews and managing interdependencies between LVE Trident, full launch, and the line transfer to Clonmel ensuringtimely resolution of schedule and resourcing conflicts between the three programs– Led a vendor change project for nephrostomy needles to reduce supply chain disruptions requiring drawing updates, DV and usability testing, while managing interdependencies with the product family’s EU MDR submission and failures during testing resulting in significant change in project scope requiring extensive stakeholder management and problem solving activities

Spencer, Indiana, United States

– Acted as Interim quality manger, supervising the production unit's quality team, ensuring robust production support, approving all nonconformance and CAPA documentation, and providing guidance to a team of 5 engineers and technicians on quality matters for a period of 6 months– Mitigated $2 million in projected backorder resulting from material stock out by implementing a quality project plan to ensuring minimal interruption production while maintaining product quality, resulting $0.5 mil in realized back order– Created content and delivered regular updates to management, site leadership, and divisional stakeholders on CAPA/NCEP progress, quality issues, mitigations, and complaint data analysis for the production unit– Supported site audit readiness through execution of informal line audits and creation of content for audits-supported front and backroom activities during external audits including leading line tours for auditors

United States

Implemented an improved training methodology under a preventative CAPA which resulted in improved training effectiveness and reduced training time saving $70k over the year in training costs in my production area. This project has since been implemented plant-wide to an estimated savings of >$500k over the year.Acted as the lead quality engineer for a yield improvement initiative that increased production yields by 7% and resulted in $1.3 million in scrap avoidance. The project focused on increasing yield by improving work instructions, engineering scrap response, station layouts, and improved training. I have led or been a key member of project teams focused on complaint reduction. These projects have included design changes, new materials, process and test method development and validation, and risk documentation changes/updates. I have broad experience in manufacturing sustaining activities and continuous improvement.

Bloomington, Indiana Area

PFMEA lead responsible for coordinating the efforts of teams working on full PFMEAs for MDFs to be remediated, leading team of 4-6 engineers. Trained COOK engineers and contractors to quality system requirements for validation and PFMEA work, generated a quick start guide to direct new engineers to training and documentation requirements for PFMEA/validation projects. Communicated with team leads and management about resource allocation and contractor performance. Established timelines and expectations for PFMEA/PVP projects, monitored progress and provided technical and non-technical direction to team members.Functional group leader for team of 4 engineers performing tooling qualifications. Responsible for coordinating qualification activities and reviewing protocol and reports for the team to meet deadlines and support other functional areas. Reviewed daily work TQ protocols and reports. Provided formal and informal training and guidance to engineers on tooling qualifications.Test method validation project lead. Developed the procedures and quality system documents for performing test method validation and tooling qualifications. Provide technical direction to TMV teams for lareg scope general TMVs and product/process specific TMVs. Established and monitored project timelines, reporting project progress and issues to management. Reviewed and generated TMV related documentation including protocols, reports, DOEs, engineering studies, and feasibility work.

Bloomington, Indiana Area

Acted as Quality Assurance Unit lead per GLP requirements Worked with management to establish quality expectations and priorities for scheduling of testing. Set quality standards for protocols and reports and kept the rest of the quality team informed of quality requirements for protocols/reports Reviewed 12 – 16 protocols and reports per week for compliance to compendial standards, quality system, and GLP requirementsActed as primary trainer on many laboratory SOP’s, responsible for training incoming personnel (engineers and technicians)Evaluated and identified gaps within the existing quality system to current GLP requirements, proposed new quality system structure and introduction of new documents to improve quality and compliance of the laboratoryDeveloped and revised standard operating procedures/quality system instructions for testing methods and processes commonly performed by laboratory personnelActed as Study Director. Supervised technicians to complete assigned laboratory studies to meet internal timelines. Analyzed data and generated reports: Average time to report completion: 7 days (47% faster than team average) with 60 studies competed in 9-month period of 2017 (25% more studies the team average)– Test Method Proficiencies: - Luer testing (ISO 594-1 and ISO 594-2; ISO 80369) - Liquid leakage testing (various standards) - BS EN 13868 methods (Adapted method for use in the lab) - Air aspiration testing (various standards) - Tensile testing of polymer tubing (various standards)

University Of Louisville

o Promotes REACH resources to students o Supervises four REACH student tutors each semester o Observes and generates tutor evaluations o Tutors students at all levels of ability in mathematics and science

o Developed experimental designs and protocols to test medical devices o Collected and analyzed experimental data o Co-authored manuscript based on research completed over the co-op period

Lexington, Kentucky Area

o Responsible for cell culture maintenance o Designed and executed experiments o Collected and analyzed experimental data

M. Eng, Bioengineering

B.S, Bioengineering