Melissa B. Email & Phone Number

Memphis, Tn, Us

Memphis, Tn, Us

Memphis, Tennessee, United States

San Diego, California, United States

• Providing management consulting across multiple industries, subjects, and areas of business, including quality engineering/assurance/control, project management, cross-functional engineering, biologics, diagnostics, biotech, medical device and throughout all phases of product life-cycle and support. • Multiple client projects, supporting internal business development requests and portfolio additions, and creating and industrializing project management performance inputs for process development and systems mapping. • Performing IVDR internal support to post market surveillance (PMS) activities for 25+ class A, B, C, D devices.• Completed literature PubMed searches and reviews, complaint findings, PMS plans, PMS Reports, Periodic Safety Update Reports, Post Market Performance Follow-up plan and reports. • Product compliance review across multiple molecular diagnostic assay support across Transcription Mediated Amplification (TMA), Polymerase Chain Reaction (PCR), and Real Time PCR (RT-PCR) technology.• Partnering with subject matter experts (SME) to complete comprehensive documentation updates, while ensuring continuous communication and weekly update meetings.• Supporting quality complaints system audit, CAPA corrections management for aging complaint reduction, and partnering with SMEs to complete in-depth investigations and root cause analysis. • Aiding in closing over 1000 complaints within 6 months, with no remaining complaints open greater than 30 days.

San Diego, California, United States

Memphis, Tennessee, United States

Stryker purchased Wright Medical in November 2020, • Managed a team of 15 cross-functional engineers through EU MDR technical documentation, compilation, conversion, packaging cutover execution, and gap remediation.• Supported Manufacturing, Operations, Research and Development, Purchasing, Sourcing, Distributions, and other Quality branches as engineering project manager through cross-functional improvement initiatives.• Fostered alignment with internal and external cross-functional business partners, utilized project management tools to effectively communicate and elevate status updates, risks, timeline/scope shifts and facilitated QMS documentation development while providing key metrics as measurable indicators. • Established and mobilized the Cost of Quality (COQ) and aided Data Management team during deployment of standardized Global Quality Operations metrics and trending.• Established the Cost of Quality baseline, metrics and trending for Quality Operations and lead Global Quality Operations projects for COQ, achieving a $1.5M cost savings/avoidance in 2020 for a 37% increase over 2019 savings/avoidance of $580K.• Established Rework Process to leverage $4M dollars of inventory in returns location at distribution centers, including Expired, Decom, Rebox and Rework, by identifying reprocessing flows, product prioritization and organizational capacity with a $1.4M resolve and a YOY plan upwards of $500K. • Implemented a reduced sampling plan across Global Legacy Wright Facilities, to optimize performance and reduced cost, lead time and backorder log, which allowed inspection reductions equivalent to $100K across 9 different part families in 4 months.• Established Tier level communication relating to Device History Record Errors and effectively reduced errors by 6%.

Greater Memphis Area

• Managed a team of 10 cross-functional engineers through EU MDR technical documentation, compilation, conversion, packaging cutover execution, and gap remediation.• Supported Manufacturing, Operations, Research and Development, Purchasing, Sourcing, Distributions, and other Quality branches as engineering project manager through cross-functional improvement initiatives.• Fostered alignment with internal and external cross-functional business partners, utilized project management tools to effectively communicate and elevate status updates, risks, timeline/scope shifts and facilitated QMS documentation development while providing key metrics as measurable indicators. • Established and mobilized the Cost of Quality (COQ) and aided Data Management team during deployment of standardized Global Quality Operations metrics and trending.• Established the Cost of Quality baseline, metrics and trending for Quality Operations and lead Global Quality Operations projects for COQ, achieving a $1.5M cost savings/avoidance in 2020 for a 37% increase over 2019 savings/avoidance of $580K.• Established Rework Process to leverage $4M dollars of inventory in returns location at distribution centers, including Expired, Decom, Rebox and Rework, by identifying reprocessing flows, product prioritization and organizational capacity with a $1.4M resolve and a YOY plan upwards of $500K. • Implemented a reduced sampling plan across Global Legacy Wright Facilities, to optimize performance and reduced cost, lead time and backorder log, which allowed inspection reductions equivalent to $100K across 9 different part families in 4 months.• Established Tier level communication relating to Device History Record Errors and effectively reduced errors by 6%. • Ensured the highest level of process and product quality while maintaining an effective Quality Management System (QMS) meeting the ISO 13485 standard and FDA Compliant Quality System Regulations.

Stryker, Previously Wright Medical

• Supported Manufacturing, Operations, Research and Development, Purchasing, Sourcing, Distributions, and other Quality branches in day-to-day operations. • Coached core team to key competencies and cultivated strong relationships in a collaborative atmosphere to ensure effective communication, active conflict resolution and successful connections to guarantee successful cross-functional alignment. • Managed 45+ projects annually, across 9 resources and multiple cross-functional business functions and product categories, to ensure successful project execution with a high emphasis on compliance.• Supervised 28+ New Product Development (NPD) projects annually, from conception throughout all life-cycle phases into sustaining, including design controls, Make vs. Buy checklists, process controls, DFM, FMEA, IOVV, RMR, H&H, PML Gates.• Maintained high quality standards for production while attaining all milestones and launch deadlines by ensuring time for print review, quality instructions, gage creation and development, validations, etc. for every successful launch.• Generated various equipment and process validations and technical reports (i.e., Gage R&Rs, equipment qualification, Validations, Quality Instructions, Overlays, Gage designs, Control Plans, Inspection plans or directions, First Article Inspections with reports, non-conformities, etc.) using advanced quality tools for multiple departments, including manufacturing and R&D.

Stryker, Previously Wright Medical

Stryker, Previously Wright Medical

Hampton, Va

Raps Executive Development Program

Engineering, Electrical Engineering And Mathematics