Darrius Edwards Email & Phone Number

Southaven, Ms, Us

Southaven, Ms, Us

Marlborough, Ma, Us

Manufacturing Engineer II/Project Lead at Boston Scientific Corporation, showcasing strong time management skills to achieve on-target Deliverables. Leading a team of 2 manufacturing engineers in spearheading the transfer and implementation of a new product line in the Peripheral Intervention division issuing a cost savings of over $250,000 USD yearly to the company. While simultaneously supporting the conversion of the current labeling system to a newly created labeling system, known as GLASS. Proactively collaborating with cross-functional teams, conducting weekly meetings, and monitoring progress via pareto and Gantt charts for seamless product family preparation. Regularly updating management on project status and executing escalation measures when necessary. • Facilitated and tracked the closure of identified gaps, promoting a streamlined workflow for Quality Documentation and compliance activities. • Collaborated with the Supplier, Quality and Production workstream, ensuring the incorporation of essential product information into project activities. • Created all SOPs for manufacturing the newly transferred product line. • Designed and installed the production area where the product will be produced. • Routed all documentation for approval through our document management system (Windchill) • Support sustaining activities such as continuous improvement by implementing a material management system to better ensure production lines have all necessary materials. • Provide initial training to the training team on the manufacturing processes of the new products. • Regularly reported the status of product transfer status to key stakeholders, providing updates on the conversion process and project milestones. • Acted as the main interface to all cross-functional teams, ensuring smooth project progression without issues. • Revised existing GOIs, PCAs, and SOPs to document the integration of the newly created GLS 3.0 labeling system.

Kalamazoo, Mi, Us

Demonstrate exceptional time management skills to ensure Deliverables are delivered on target. Lead a team of 3 manufacturing engineers through the process of EU MDR conversion for the Lower Extremities division of Wright Medical, now Stryker. Collaborate with cross-functional teams to ensure all product families are prepared for conversion by holding weekly meetings and tracking progress in a pareto chart. Communicate with management on the status of the project and perform escalation events as needed. • Support team regarding Tech-Documentation submission, Package and Labeling needs and Direct Part Marking Quality support, • Serving as the main interface to RA for Quality documents related to the Tech-Documentation, Package and Labeling needs and Direct Part Marking Quality support, • Tech-Documentation compilation for Quality Documentation, • Gap Assessments reporting (early and exact) and correction, • Managing and tracking gap closure activities for Quality Documentation, • Liaising with team and suppliers for supplier information relating to the activities above, • Reporting out on the status to Directors the status of product families as each is converted. •Leading the team regarding MDD to MDR conversion for the Arlington site. •Serving as the main interface to all cross-functional teams to ensure project progression is occurring without issue. •Collection of product data of formation of spreadsheets to house data. •Tech-Documentation compilation, •Supplier communications to ensure MDD to MDR conversion happens seamlessly. •Facilitating and tracking the closure of Gaps identified. •Liaising with Supplier workstream to incorporate supplier information into the activities above. •Reporting out on the status (internal and external manufacturing).

Warsaw, Indiana, Us

Zimmer Biomet Spine Memphis, TN 06/21- 09/21The Senior Quality Assurance Specialist is responsible for performing and conducting routine final inspection and DHR release of medical devices and related documentation. The technician is responsible to perform moderate to complex visual/mechanical inspections, deciding whether or not the parts conform to specifications, and documenting these decisions and supporting data. The Technician will assist management as needed with general support, leading on-the-job-training for Product Assurance Clerks/Specialists, and special projects.Audit and verify technical information (router packet, product container and identification, blueprint, label information, packaging setup sheet and all other technical information in the packet) complies with DHR requirements.Analyze data to determine accept/reject final disposition. Document decisions and relevant data using reports, database systems and instruction sheets.Document all activities in a manner compliant with good documenting practices Performs audits of manufacturing areas to assure compliance to approved procedures.Review manufacturing processes and records for compliance to internal procedures and FDA/ISO requirements. Generate Non-conformance Reports for submitted product found out of specification Communicates with manufacturing cell members, manufacturing management and engineers concerning product and documentation defects or issues limiting optimal cell performance.Utilize shop math techniques (addition, subtraction, multiplication, & division), dexterity and mechanical aptitude to operate precision equipment Complete tasks accurately and on-time, paying close attention to detail.

St Petersburg, Florida, Us

Provide critical process engineering and process quality based decision making, and implement strategic and tactical plans to improve output efficiency, quality, and over-all productivity for this third personal protective equipment manufacturer encompassing 1.5 million sq. ft. and 700+ employees. Oversee all aspects of processing / packaging line operations (NP Medical, Inc. Products) while supporting all aspects of manufacturing operations (compliance with corporate, OSHA, FDA and Safety Standards, Quality Control, Team Participation, and PST (performance of assembly level tasks).Have implemented Over 6 LEAN / KAIZEN concept initiatives within the project management team procedures.Use advanced quality production and troubleshooting skills to maintain hourly quotas for the manufactured products; maintain a track record of high productivity in this fast-paced environment.Developed and implemented all Engineering policies and practices to improve performance, reduce waste, delays, and costs; monitor yield trends and perform random sampling according to work cell processes, and; record all findings and provide feedback to Line Managers.Provide ongoing review regarding effective utilization of production methods, equipment layout, material handling, personnel, equipment, and material.Hire, fire, evaluate and develop staff (technical certifications) to ensure that all responsibilities are carried out to the required standards; continually upgrade training requirements for staff.Continually review operational procedures and designed/implemented preventive / corrective maintenance programs to ensure continuous and high-volume production.

Watford, Hertfordshire, Gb

Packaging Laboratory Earned the confidence of management to serve in a critical multi-function position in personnel management, production and quality/inspection. Support Packaging Test Engineer with all package integrity, product sterilization, biocompatibility testing, machine validations and calibrations, product validation, test flow execution activities, and distribution logistics within this 50,000 sq. ft. packaging laboratory. Maintained various laboratory equipment utilizing solid technical, quality control, and machine maintenance skills. • Produced numerous production scheduling and daily output reports and associated documentation for submittal to upper management. • Responsible for ensuring sustained lab organization and flow per 5S practices. • Utilized CAD Design System to design innovative packaging solutions; • Established a record of career and professional growth in working on various primary daily laboratory functions and in preparing samples.

Memphis, Tn, Us

Fedex Supply Chain is a subsidiary of Fedex that specializes in supplying hospitals with medical products from vendors that are housed in our facility. My job duties are to monitor, and inspect all incoming and outgoing products and ensure there are no signs of damage or tampering. I document my findings and submit a report at the end of every day to my supervisor as well as customer service. We have several accounts that we currently house, I manage all customer accounts. If we receive any damaged product directly from the client I immediately take pictures, and write a Non-Conformance to be sent to the customer. Here at FedEx Quality works closely with the Operations team to ensure that every Fedex experience is a good one. Also part of my role as a QCS is to continuously improve and update all SOPs to ensure that we are providing our clients with the best service.

Quality Manager Significantly improved multi-tasking and leadership skills in simultaneously managing multiple project to include: 1) Supervising Laboratory technicians who are responsible for daily chemical, physical and microbiological testing of products, 2) Managing Blend Technologist and Quality Analyst who are responsible for daily quality, CoA generation, blending, labeling, production planning, outside laboratory testing, and equipment maintenance, and 5S standards, and 3) Providing leadership, planning, and technical expertise to the laboratory and manufacturing staff. • Managed and coordinated daily duties for the Internal Audit Team by identifying training requirements of auditors, training auditors, scheduling audits and evaluating audit effectiveness. Reviewing, preparing and approving documentation (policies, procedures, instructions and forms) as necessary for ISO certification, and introducing and training new employees to ISO concepts. • Performed quality reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records. • Managed HACCP program and Food Safety Program as required by FDA.

Deerfield, Illinois, Us

Responsible for chemical and physical analysis on medical products through all stages of the manufacturing process from incoming raw material through to product release.· Identifies and develop strategies, performance indicators and project improvement opportunities.· Set department goals/expectations, provide performance feedback to employees and managed performance daily.· Responsible for organizing and implementing QA plans, inspections procedures and sterilization projects that met all state and FDA regulations requirements for pharmaceutical products.· Designed and completed protocols to enhance the Environmental-Monitoring Program.· Create and manage quality assurance inspection instructions per established guidelines to maintain operator awareness, without impacting product.· Address all out of limits and positive test results by completing trending analysis (OOL, NCRs, Trackwise investigations), retest procedures, gram staining, thermal death testing, microscopic analysis, aerosol challenging etc.· Organized and performed sterilization validations (steam, dry heat) annually, required for Sterility testing and Environmental Monitoring sampling.· Develop steam sterilization studies and provided solutions to product development in the department.· Evaluating sterile processing products for better performance vs. cost efficiency.

Cleveland, Ms, Us

I functioned as a business consultant within the DEBTS Program in the College of Business at Delta State University in Cleveland, MS. The Debt Education for Business Transformation and Sustainability (DEBTS) program was a program funded by a USDA grant that aimed to help small businesses in the Mississippi delta grow and become financially profitable and sustainable businesses. My job duties consisted of meeting members of the program and having them teach my about their business so that I can form a business plan that will best suit their needs. I would then visit members every day to ensure that the revitalization plan is being implanted correctly and smoothly. I also monitor the impact the plan is having on the business and make adjustments accordingly. Some daily activities include jobs such as assisting clients move to a different location, assisting with marketing techniques, and reviewing financial records to access where and how the company can save/make more money.