• Direct business development B2B, Cloud, SaaS markets in Healthcare, Payer & Insurance, leveraging extensive experience in quality systems and regulatory compliance to understand client needs.• Manage and execute the sales process for Hendren's AI workflow automation software platform, utilizing expertise in process optimization and automation gained from implementing quality management systems.• Cultivate and develop relationships with prospective clients to identify, qualify and develop quality sales opportunities, focusing on new business. Apply skills in cross-functional collaboration and stakeholder management developed during quality improvement initiatives.• Manage full sales cycles from lead to close, including contract review and contract negotiations, drawing on experience in regulatory response assessments and compliance management.• Develop and manage a robust sales pipeline to consistently close business, applying analytical skills honed through trend analysis and KPI management in prior quality engineering roles.• Actively participate in industry-relevant trade conferences and events, leveraging experience in presenting and implementing quality initiatives across organizations.• Collaborate with cross-functional teams including marketing, product, and customer success, utilizing expertise in working with R&D, manufacturing, and regulatory affairs to ensure product quality and customer satisfaction.

• Selected to lead Document Management harmonization across C.R. Bard and BD’s QMS; this included SOP gap assessments, identification of inconsistencies and implementation of standardized controls for impacted processes. Further streamlining the business integration while enhancing compliance and quality of the systems. • Managed cross-business QMS compliance right-sizing program as the Key Quality Assurance liaison; which served to periodically assess critical quality process, ensuring that they are aligned with standards / regulations. This included removing unnecessary activities to promote streamlined processes. • Developed automated management of field actions and recall analytical data for all BD interventional products, namely coated balloon catheters to identify trends, determine financial impact, and lead development of remedial action plans. • Quality collaborator on beta testing of the Tulip software platform for eDHR development tasks by reviewing and approving validation summary reports as well as providing immediate feedback on any risks and mitigation strategies.• Developed and implemented the regulatory response assessment program, ensuring timely and comprehensive responses to agency inquiries, this included consolidation and integration of feedback from international Quality partners.• Led Root Causes Analysis approvals for responses to regulatory agencies, ensuring investigations were robust and effectively identified root causes and corrective actions.• Developing and managing Site KPIs through implementation of trend reports, ensuring issues critical to production and product safety / performance are escalated, root causes are identified and issues mitigated.

• Selected to lead complaint backlog reduction while addressing FDA observation, implemented strategy to execute, investigate and successfully close 300+ complaints.• Led Quality initiative to drive down FCZ product complaint rate, which was trending at 8% of all complaints. Worked with R&D for the identification of product issues identified within trends then addressed root causes, effectively dropping complaint rate to 1.8%.• Implemented strategic Danaher Business System tools such as kaizen, 5S, kanban and poka yoke to streamline and help standardize quality control workflow on manufacturing floor as part of continuous improvement and lean processes. • Effectively communicated production issues to CAM/product development teams. Streamlining the implementation of remedial CAPA activities through the organization of Quality Councils and ensuring customer product requirements were met. • Implemented Visual Management and Quality tools like Control / Pareto Charts, clearly identifying and prioritizing complaint trends, root causes and corrective actions.• Directed quality improvements to the complaints handling process, enhancing trend identification, and improving the quality of corrective actions. This process transformation subsequently became the gold standard within the organization.

• Led cross-functional collaborative discussions with R&D and Manufacturing to build PFMEAs, develop NCMR/SCAR resolutions, analyze engineering drawings/geometrical dimensioning and tolerancing, review BOM structures of product designs. • Improved speed-to-manufacturing release of quarantined component parts to maintain compliance and lean by dispositioning over 100 non-conformance parts on daily basis.

• Collaborated with software group to ensure functionality of system by verification of software; evaluation of performance on complex diagnostic immunoassay instruments.

• Optimized process by building SPC analyses, composition of IQ/OQ/PQs, equipment validations, and temperature mapping for industry incubators as part of DHF record.• Lead design review board meetings to review findings and identify agility opportunities upon assessment of Class 8 cleanroom.• Performed internal quality audits to ensure proper quality is met in handling cow tendon upon receipt into facility and its processing to collagen.

• Managed 30+ label claim change renovation projects by compiling technical dossiers to support expansion of product availability in global regions. • Organized accelerated stability testing, ensured formula specifications are met, and partnered with pilot plant on the industrialization of bench level to large scale batches. • Responsible for process development and scale-up, stability, and manufacturing process optimizations for over 15 currently marketed products • Successfully facilitated the release of products by leading cross-functional teams with regard to technical aspects of formulations• Assumed the role of lead rush investigator for projects with compressed timelines to meet costumer need while maintaining a sound basis for release