CQRO, Co-founder, and leader of a team bringing groundbreaking machine learning solutions to ICUs with a focus on critical pulmonary care.

Full-service quality and regulatory consultancy specializing in assisting companies with internal audit requirements or assessing certification readiness. Partner with multinational and not-for-profit healthcare companies to analyze gaps between current practices and regulatory standards. Manage audits, provide regulatory consultation, establish corrective action remediation and deliver effective quality training.Provide consulting expertise on regulatory standards including but not limited to ISO 13485, ISO 9001, IEC 62304, 21 CFR 820, MDR, IVDR and MDSAP.Achievements:• Developed global regulatory assessments for startups associated with WNT Ventures, NZ• Established 62304 compliant software development procedure and templates for non-medical division of a non-medical division of a surgical robotics company • Successfully contributed to the customization, implementation, and validation of eQMS adoptions • Engaged by a surgical 3PL as a director level consultant to advise on the adoption of ISO 13485:2016, RFID sterilization, and software validation. Saved the company $250, 000 in sterilization validation costs.• Successfully contributed to the establishment of the new European Commission's In Vitro Diagnostic Regulation quality standards within Roche Diagnostics – Ventana ($100 million annual revenue). • Led and managed contract manufacturer’s compliance audit (ISO 13485:2003) for Children’s Healthcare of Atlanta ($1.3 Billion in revenue, 70 sites).

Hired as an integration team member to assist with the onboarding of a newly acquired software as a medical device company. Achievements:• Provided design quality and risk management expertise to create and remediate technical documentation to successfully get 2 products (including software as a medical device) EUMDR certified• Managed 5 CAPAs and their respective teams during a 9-month period to resolve root causes and align with an ongoing manufacturing transfer. • Coached the hardware and software development teams on good design practices and maintenance of software documentation to maintain compliance with both US FDA regulations and EUMDR in preparation for multiple regulatory submissions (EUMDR, 510K, and pre submissions).

Advised as a compliance expert on critical/complex global projects and corporate quality and regulatory due diligence activities. Responsible for the global coordination of internal site, supplier, and FDA readiness audits. Coordinated the customization, maintenance, and validation of the EtQ Audit Module.Achievements:• Managed a team of 3 auditors across multiple time zones to successfully meet rigorous internal and supplier audit schedules• Evaluated the execution of EU MDR implementation. Closure of improvement suggestions resulted in passing notified body EUMDR audit. •Advised on the implementation of three business acquisitions/integrations resulting in the successful expansion of ISO certifications. • Successfully collaborated on a compliance department simplification project to reduce process waste and increase internal audit value by streamlining 3 processes: audit planning, execution, and reporting.

Provided expertise consulting in quality improvement and regulatory compliance to a division that lacked quality in medical device software development. Provided leadership in project management, development of work plans, design decisions, document development, and corrective and preventative action planning.Achievements:• Provided quality planning consultation services on a $4 million project to develop a novel medical device mobile application. • Overcame resistance and team objections to successfully implement a software design and development process compliant with IEC 62304, ISO 13485, ISO 14971 and Philips global QMS requirements. • Achieved success in coaching teams in the implementation of quality practices, while outsourced to other business units within the Population Health Management Division. • Orchestrated a remediation project to organize risk file documentation (fMEAs, hazard analysis, etc.) and related product testing to comply with new Radio Equipment Directive (RED) standard resulting in company maintaining CE Mark and ability to sell devices in Europe.• Developed documentation and procedures process to comply with MDR, IEC 62304, ISO 13485, ISO 14971 and other regulatory updates.

Oversaw a multidisciplinary team of scientists in the design and development of a diagnostic aid (software) for Autism Spectrum Disorder. Led the design and development of a compliant quality management system.Achievements: • Launched an electronic QMS software that increased document and record control compliance and reduced document approval time by on average 3 days. • Implemented a risk-based supplier management process to improve the selection process of qualified vendors and contract manufacturers.• Coordinated the processes that governed the business in establishing an ISO 13485 based Quality Management System resulting in compliant development and prototyping. • Provided expertise and education to organizational leaders to establish compliant design documentation for the design history file to increase entry rates of clinical trials.

Led the maintenance of a nationwide human tissue field audit program providing oversight to approximately 85 sales representatives across the United States. Provided disposition management of all human tissue products returned to the Global Distribution Center in compliance with AATB Standards and 21 CFR 1271.Achievements: • Identified and implemented a cost-effective temperature monitoring program that decreased errors and increased compliance with temperature monitoring requirements. • Successfully led the human tissue department through 3 FDA audits, 1 supplier audit, and 1 third party audit with no deficiencies. • Improved established shipping return methods which decreased tissue scrap rates, saving the company approximately $100000 per month.• Collaborated with tissue suppliers and packaging engineers to improve printing legibility resulting in a decrease in error and a decrease in scrap expenditure

Promoted from Technical Service Engineer to manage the Cryobiological Division spanning 3 manufacturing facilities. Conducted internal training classes on ISO 13485 and Medical Device Directive standards. Provided education and guidance to operations personnel to diagnose root causes and implement corrective actions. • Charged with quality assurance services including assisting associates in performing internal audits and external audits across multiple continents with strict adherence to audit plans. Achievements• Managed the Post Market Surveillance, CAPA and complaint system for the cryobiological family of products.• Spearheaded the establishment of metrics to assess and verify the attributes, characteristics, quality, and qualifications of products in accordance with established standards.

Delivered superior training, support, and service by conducting classes and work sessions, troubleshooting product issues, and responding to product and service inquiries through comprehensive information gathering, excellent communication skills, and inter-departmental relationships.Achievements:• Collaborated with the Director of Quality to create a quality analyst position/job description based on established ASQ Process Analyst Certification.• Led a supplier improvement initiative which resulted in the reduction of warranty exposures by 50% for a high-profile product line.• Maintained Label Update project to ensure compliance with new EU symbols.• Involved in team and client discussions to bridge the knowledge gap between customers and engineers.