Tiffany Simek, MBA
Implementation Consultant at L2L- Claim this Profile
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Credentials
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Confronting Bias: Thriving Across Our Differences
LinkedInSep, 2021- Sep, 2024 -
Diversity, Inclusion, and Belonging
LinkedInSep, 2021- Sep, 2024 -
Leading Your Team Through Change
LinkedInSep, 2021- Sep, 2024 -
Leading with Emotional Intelligence
LinkedInSep, 2021- Sep, 2024 -
Lean Behavior-Based Safety Internal Consultant
ProAct Safety, IncSep, 2018- Sep, 2024 -
Green Belt (Teleflex)
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Experience
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L2L
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United States
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Software Development
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1 - 100 Employee
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Implementation Consultant
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Oct 2021 - Present
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Mallinckrodt Pharmaceuticals
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Sr. Performance Excellence Specialist
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Aug 2020 - Oct 2021
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Halyard Health
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United States
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Hospitals and Health Care
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400 - 500 Employee
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Lean Coordinator
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May 2015 - Aug 2020
Responsible for the implementation and continuous improvement of LEAN manufacturing practices. Provides expert consultation to all of the plant teams to implement and maintain LEAN practices to eliminate waste in the team’s value streams and daily business practices. Responsible for work streams across the facility and to develop and drive results through the plant’s core values of safety and quality, and key strategic initiatives. Coordinates projects with site leadership. Responsible for training 200+ employees. • Plan, coordinate, and execute the Lexington Site Strategy Deployment Session • Align the plant with corporate’s short and long-term business strategy. • Audit Command Center Lead and Strategist. • Support the QMS policy and compliance by contributing to the development, implementation and continual improvement of the effectiveness of the Quality Management System. The QMS requirements include Halyard Corporate QMS, FDA Part 820, ISO 9001 and ISO 13485. Identify, report, investigate and address nonconformances. • Provide training on Simple Problem Solving and facilitate sessions. • Lead Validation Process Mapping sessions to develop a Lean flow for validations. • Lead weekly housekeeping audits. • Site refresh to create a World Class Health Care Manufacturing Facility including values, vision, mission, and foundations as a means for delivering manufacturing results. • Implemented and Lead weekly Chronic Issues meeting. • Implemented Visual Plant Metrics Board • Team leader for the Behavior Based Safety Observation Program. Other Duties/Volunteer : • 2018 Leadership Davidson County Program • Halyard Health Site Campaign Lead for United Way of Davidson County (2016-2019) • United Way of Davidson County Funds Panel (2016-2019) • Halyard Health Site Team Lead for Wellness Program – lead 10 volunteers (2017-2019) • Halyard Health – NC Star participant (yearly convention) • Halyard Health – Lean Behavior Based Safety Internal consultant Show less
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Teleflex Incorporated
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Netherlands
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Mining
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1 - 100 Employee
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Sr. Process Engineer-Strategic Manufacturing
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Oct 2011 - May 2015
Prior Position with Teleflex: Process Engineer •Provide engineering support to manufacturing operations. •Completed Teleflex Green Belt Training: Successfully implemented a lean line, reduced lead time by 65%, reduced travel distance by 61%, and reduced footprint by 43%. •Facilitated Continuous Improvement suggestions to improve ergonomics, floor space, and visual aids. •Provided Poka-Yoke training to Engineering Team and in Green Belt training. •Lean Manufacturing – value stream mapping to help understand the flow of the process and identify waste. Created fishbone diagrams to help identify potential root causes. Utilize lean principles in daily manufacturing operations. •Lead failure investigation for product complaint. Implemented process documents to have visuals on assembling product. •Plan, create, and execution of multiple validation plans (protocols and reports) for Installation Qualification, Operational Qualification, Performance Qualification, User Requirements, Performance Development, and Master Validation Plans for new packaging trays, device manufacturing, and equipment. •Assist in FDA audit, mock FDA audits, customer audits, and BSI (British Standards Institution) audit. •Trained new hire Sr. Engineer on validation process. •Mentor to new engineers. •Project lead for $1.8M Clean Room Building Modifications. Designed and implemented. Show less
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Energizer
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France
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Spectator Sports
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1 - 100 Employee
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Engineer
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Sep 2007 - Jun 2011
As a team member of the Alkaline Equipment Engineering Department, I support specific machines at the Alkaline Battery Manufacturing facilities worldwide. Based out of the R&D Facility in Westlake, OH, I travel to the plants to support maintenance, expansion, and design projects. I recently gained valuable international experience in our Singapore facility by building and installing equipment to support production expansion. I am proficient at project management related tasks such as requesting capital and expense funds, estimating project costs, billing, R&D, project leadership, and reporting. Show less
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Eberhard Manufacturing
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United States
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Motor Vehicle Manufacturing
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1 - 100 Employee
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Mechanical Drafter
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Jun 2003 - Sep 2007
Light Design work: Design and redesign products for industrial and vehicular hardware Create Bills of Materials using Lilly Software: Visual EnterpriseResearch and develop prototypesAssisted in administrating Engineering Notice Meetings
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Associate Design Engineer
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Jun 2003 - Aug 2007
New Product Development Product DesignDevelop cost estimates for new products using ExcelResearch and develop prototypes.International Material Data System (IMDS) reports
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Junior Engineer
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Dec 1997 - May 2003
Use Design Engineer Assembly layouts in AutoCAD to create detailed subassemblies, machine parts, Bill of Materials, main machine assemblies, and release detailed booklets for machine assemblers Create detailed AutoCAD drawings from supplier's catalogs for use in designing specialty machines Order machine components from suppliers using cut sheet and order recognition form Light Design work: Reworked machine parts, created machine layouts, and designed machine doors Created Catalog library using Access Developed Engineering hours time sheet using Excel Show less
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Education
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Trident University International
Master of Business Administration - MBA, Strategic Leadership -
Cleveland State University
Bachelor, Mechanical Engineering -
Cuyahoga Community College
Associates of Applied, Science Mechanical Engineering Technology Degree -
POLARIS CAREER CENTER