Michael Sosebee Email & Phone Number

Pittsboro, Nc, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

• US Quality Management Representative- Manager of TransEnterix’s US-based Quality Assurance team (2 direct reports)- Interface daily with TransEnterix’s Italian based Quality Assurance team and Manager to ensure the quality system is supporting business objectives- Helped organize and lead Management Review per ISO 13485 & FDA Part 820.20 and TransEnterix’s Product Evaluation Board to evaluate changes to address post-market review of the Senhance Surgical System• Senior Quality Engineer & Software Project Manager- Organized and led the software response to the FDA AI request of K171120 (first 510(k) of the Senhance Surgical System), assisted in developing the following 510(k) submissions K180163, K181517, K183098 and K182421- Developed, implemented, and managed a new software development lifecycle (SDLC) to improve the Senhance software- Implemented an agile development and verification methodology to release Senhance software on a 2-month release cadence to address customer complaints, CAPAs, and internal feedback- Performed investigations and was part of the decision board to determine if a customer complaint was reportable to TransEnterix’s notified bodies and/or the FDA- Led the backroom team during the first FDA inspection- Developed and implemented a streamlined change control process to ensure timely cross-functional reviews were performed when requesting and implementing a change to the Senhance Surgical System- Developed, automated, and maintained a Quality dashboard providing a daily & weekly summary reports of the QMS. The dashboard was adopted for inclusion in Management Review, Product Evaluation Board & weekly Global Quality meetings- Supervised two Quality Engineer and one Quality Specialist- Managed a project with a software consulting firm to develop a mobile & web-based application to provide a digital replacement to TransEnterix’s paper-based complaint and feedback process

Apex, Nc, Us

Project Manager (4 years)-Defined project goals and objectives by discussing the problem with the client and end users.-Provided leadership to team, ensuring the planning of tasks into sprints, and coordination of different functional groups -Maintained the project’s scope by implement change control and performing a cost-benefit analysis.-Documented and implemented a project plan which divided the work into the five phases of our SDLC, including concept, requirements, specifications, design, construction (development & verification testing) and validation testing.-Managed three projects, monitoring the project’s cost, schedule, performance, budget, and resource utilization.-Reported to our Director of Operations on the cost, schedule, performance, budget and resource utilization of six other ongoing projects.-Prepared and utilized project management tools to track and coordinate with our Director of Operations.-Maintained project documentation and ensured the design history file was updated during each phase.-Developed and analyzed organization workflows to ensure the projects were utilizing an efficient and effective process.-Scheduled and lead project meetings including; scrum (agile), code review, design review, change control board, status update, phase review, sprint retrospective and project retrospective, by preparing agendas, documenting meeting minutes and delivering status reports.-Adhered to good documentation practices and implanted best practices from my ASQ-CSQE certification, ISO 9001 & 13485 compliance and FDA 21 CFR 820 guidance.

Raleigh, North Carolina, Us

Instructed E115, Introduction to Computing Ethics at NC State:-Prepared & presented lecture material (covering topics from computer hardware and operating systems to development of webpages using CSS and XHTML)-Administered exams and graded completed work on a weekly basis

Minneapolis, Mn, Us

-Assisted customer with choosing appropriate products-Led closing team in zoning store-Inventoried overstock in backroom

Master Of Science - Ms, Regulatory Affairs - Medical Devices

Bachelor Of Science, Biomedical Engineering