Part of the Senior Management Team and Foundational department member for a Software as a Medical Device (Mobile Apps) Digital Therapeutics company. Responsible for building up systems from scratch to scale for US and UK/EU territories. Handled all aspects of quality regulatory system: ISO, MDR, FDA QSR, and Germany DiGA building out a risk appropriate system that integrates with coworkers day to day tasks. Achieved ISO 13485 & ISO 27001 Certifications, MDR Class I and 510(k) Class II clearance. Responsible oversight of several areas for the company: Clinical Operations, Customer Support, Medical Affaits, Cybersecurity, Compliance

Oversee the Quality department and practices to create a site wide fully burdened quality management system. Establish Quality team and foster best practices for an advanced biotech with extremely modern testing systems in software and hardware automation in an aggressive change mode. Develop, deploy, monitor and continuously improve upon all aspects of Quality Management System under the guidelines of a Clinical Diagnostics Laboratory Developed Test service model while maintaining the ability to quickly implement to any regulatory paradigm. Owner of EH&S and responsible for establishing and maintaining CAL OSHA compliance, all federal, state and local regulations concerning employee and product safety, management of bio-hazardous and chemical waste streams, and creating a culture of best practices in safety awareness.Support site in developing best practices in Global Regulatory, Quality, Clinical Compliance, Organizational Excellence, Lean manufacturing and Customer focus.Executive oversight of transformation of reagent manufacturing for scale, reproducibility, reliability, visual control and other principles of operations excellence.

Hired to found the QARA department in a biotechnology medical device start up. Report to the COO. Responsible for building QMS throughout the organization in accordance with FDA QSRs and ISO13485. Responsible for regulatory oversight, submissions and design history file.Direct project, strategic and tactical management over the establishment of an outsourced manufacturing line of high dimensional sensor arrays under AS9103 guidelines from scratch.

Responsible for building the Quality department from scratch and developing Quality infrastructure throughout the organization in accordance with relevant ISO or cGXP standards. Strategically Plan and tactically execute quality planning to bring the company from a development / start-up state to a fully mature operations facility.Develop, deploy, monitor and continuously improve upon all aspects of a fully implemented Quality Management System.Manage site global regulatory for: Design, development, transfer, associated submissions and compliance for products and services needing medical device and IVD regulatory requirements.Support site in developing best practices in Global Regulatory, Quality, Clinical Compliance, Organizational Excellence, Lean manufacturing and Customer focus.

Hired and developed team of 7 employees for medical device start up company, company management representative for regulatory compliance and report directly to CEO. In charge of planning and implementing an ISO 13485:2003 compliant quality systems for site. Initiated and obtained California state manufacturing license for medical devices. Have responsibility for all regulatory, internal and supplier audits. Hold fiscal responsibility for the department. Established, scheduled and lead quarterly management reviews. Train departments in design control, CAPA, Root Cause Analysis and cGMP standards. Strategic planning for continuous improvement and tactical daily functions.Handle 510(k) submissions and regulatory guidance for new projects and product.

Hired and developed team of 10 employees, report to Director of QA/RA. In charge of document control for site and helped develop new NCR/CAPA. Responsible for internal and supplier audits. In charge of department finances and budget. Responsible for ISO13485: 2003 compliance, site validations and protocols. Implemented on site SPC software for real time statistical analysis. Train new clients on the CLA-1 allergy screening system at client site. Implement ongoing training program for new customers, including developing a 360-degree feedback loop after initial client training. Successfully led multi-functional teams focused on cost cutting, process improvements and safety, saving $85k a month to bottom line. Led strategic implementation of organizational development through process improvement programs such as TQM, SPC and root cause analysis. Designed Quality Control product, which reduces customer QC costs over 18% and increases profitability 10%.

Senior management team member and reported directly to president; managed staff of 6.Released raw materials, reviewed product specifications prior to launch. Created SOP'sfor department. Wrote and performed cleaning validations. Investigated non-conformingmaterials. Managed Cal-OSHA relationship. Worked with FDA 483 issues. Audited rawmaterial suppliers. Implemented product stability program, extending product life from 3to 12 months.

Reported to Quality Control Manager and supervised 3 employees. Implemented a newmicrobiological method for speciation of bacteria and a new API speciation system toidentify potentially harmful bacteria. Tested and released raw materials, in-process andfinal products for microbiological safety. Managed customer complaints. Performedsupplier audits.

Reported to Quality Control Manger and supervised 2 employees. Tested and releasedraw materials, in-process and final products for microbiological safety and efficacy. Handled and investigated customer complaints. Developed specific microbiology testingprograms on client sites.

Reported to Quality Control Manger. Tested and released client products forMicrobiological safety. Managed laboratory inventory and product stability program.Developed a fat test for low-fat salad dressings without the use of ether. (An unstable anddangerous chemical)