Providing business and technical leadership of new product development programs within the Baxter Renal business.Management of a $25M annual new product development program which integrated electromechanical device, water purification, disposable, drug and remote software technologies.Led the cross functional team to scope, plan and finalize the execution plan to successfully support the FDA clinical trial submission for Baxter's next generation PD system. Responsibilities included the strategic planning and execution of manufacturing builds for electromechanical, disposable and drug investigational product production, service and clinical readiness, and logistics planning.

Provided support to the Sustaining Product Core Team (SPCT) leaders by planning, scheduling, executing, monitoring, and controlling activities to fulfill identified SPCT objectives.Applied technical, theoretical, and managerial skills to satisfy project requirements. Directed multiple cross-functional sustaining product governance teamsDrove clarity by defining and prioritizing the project portfolio objectives, critical success factors and deliverables for the core team, and ensures that supporting project teams meet schedule, scope and cost commitments.

Processed complaint tasks for Renal Peritoneal Dialysis disposable products by reviewing complaint information, conducted labeling reviews, assigned problem and cause codes as well as determined whether further investigation is needed for product issuesExecuted complaint trend investigations, Corrective and Preventive Action (CAPA) and Field Corrective Action (FCA) assessment activitiesIdentified and escalated potential product issues, quality system issues, and recommended process improvementsPlanned, monitored, controlled and implemented design control and risk management projects within the guidelines of the organization’s project life cycle process, standard performance metrics, and regulatory guidelines

Evaluated and processed customer complaints with a strong focus to detail in accordance to medical device regulations and quality system requirementsDetermined complaint reportability in conformance with US, EU and Canadian regulations.Collaborated with Quality Engineers to track trends and initiate complaint investigation activities as needed.

Partnered with project managers and technical support scientists to meet the site’s demand for product availability, compliance to regulatory and quality requirements, and divisional product/process improvement change requests.Negotiated and prioritized multiple projects, project resources and project completion dates with divisional site management to align with the site’s demand.Applied scientific knowledge and logical thinking to determine any technical verification or validation activities necessary to support manufacturing and testing changes

Partnered with Division/Region/Functional Areas representatives to gather industry quality inspection data across Baxter and update central repositories with pertinent information.Evaluated and interpreted industry inspection observations to assign quality system categories and risk ratings.Maintained an updated matrix of all FDA and all other regulating agencies’ citations/enforcement letters to be used for Corporate Compliance Services Metrics Reviews and Quality Scorecards.Prepared monthly highlights regarding industry inspections and presenting them to the Corporate VP of Quality.