Leading transition to MDR. Implementing project governance structures to ensure rapid and effective transitioning to the new unified MDR certified Quality System. Responsible for managing Quality, Regulatory, Sales and Supply Chain teams, including improving and harmonizing business processes to support business growth.

Responsible for quality and regulatory affairs for SaMD business units during critical scale up phase. Lead cross functional team to transition from MDD EU 93/42 to MDR EU 2017/745. Update Quality and Regulatory processes to comply with the new regulation.Leading improvements and optimizations to NC, CAPA, Compliance, and Document Management to support business growthOrganize and chair cross functional team meetings to prioritize and set direction for QA & RA efforts.

Provided guidance and consulted on Quality and Regulatory strategy for growing medical device division of COMATE.

Provide Systems support for development of innovative rapid COVID-19 breathalyzer test. Project ONE is developing a test that takes only five minutes to provide results and can be executed at the point of use. Project ONE will create a fast & reliable PCR test that can be deployed on site and with the use of controlled automated processing produce results outside of a BSL laboratory. Responsible for leading and supporting risk management, verification, and validation activities, overseeing and coordinating testing within very aggressive project timelines.

Responsible for supporting digital dentistry from a quality and compliance perspective. Lead cross functional team to address quality and compliance needs of growing digital dentistry business. Liaise with R&D to ensure new software development is in compliance with applicable requirements, including ISO 62304 & GDPR. Implemented always audit readiness strategy which incorporates inputs from, external audits and inspections, internal audits, NCR/CAPAs and quality data to ensure risk are addressed or mitigated and keeps QMS in state of always audit ready. Lead development of new complaints software developed by external supplier. Coordinated activities internally, including collection of requirements, harmonizing with company procedures, planning testing, and ensuring compliance to CSV procedures and standards.

Manage ELC Supply Chain quality systems, including but not limited to: CAPA and Nonconformance, management review, internal auditing program, and external audit readiness program.Act as site lead for (WW) Quality system related projects including implementation of internal Johnson and Johnson standards, and external standards such as ISO 13485:2016.Lead on-going efforts to improve ELC Quality System, update and streamlining of Quality system processes and procedures.

Manage Cell Teams (cross functional product teams) for assigned products (anesthesia and multiple patient monitor lines). Review all quality metrics, initiate investigations and escalate appropriate issues to CAPA team.Key team member in initiating new manufacturing procedure validation process, re-validating approximately one hundred manufacturing processes to new requirements in under three months.Function as CAPA assignee (lead) or assist in investigations for assigned products. Prioritize CAPA tasks based on risk and business needs. Work with R&D/Engineering department to complete investigations. Prepare CAPAs for closure by the Review Board, report status of open CAPAs.Assist Regulatory Affairs department in evaluating customer complaints and determining whether formal investigation is required.Manage Receiving Inspection, Functional, and Quality Test procedures for assigned product lines.Assist in protocol and test report review for 510k submissions. Review and approve Change Request, including new and revised manufacturing procedures, drawings, and operators manuals. Developed and assist in the management of the IEC60601 Third Edition readiness plan for products requiring CE marking.

Improved all quality system metrics: Moved from paper based data capture and reporting to fully electronic and automated systems. Reduced time necessary to generate such reports by 80%, as well as decreased time necessary for operators to enter data and increased the accessibility of data to key personnel in the organization. Primary responsibility over CAPA System. Updated internal process and procedure to align with current FDA, ISO and customer requirements. Provide CAPA training and investigation assistance to all functional groups. Primary responsibility for improving and maintaining Supplier Quality System. Working in conjunction with purchasing to: track and trend supplier performance, perform supplier audits, issue supplier CAPAs and assist with root cause investigations.Facilitated and coordinated bi-annual Management Reviews per ISO 13485, 9001 and FDA 21 CFR Part 820 requirements. Responsible for reporting to top management the health of the quality management system; including collecting, analyzing, summarizing and prioritizing data relating to the system's current state and its effectiveness.

Working with all members of production team in a GMP environment to ensure continuous improvements of processes by maximizing efficiency related to resources, personnel, and time. Responsible for collecting data concerning manufacturing efficiencies. Worked closely with plant supervisors to develop a more concise, accurate, and thorough metrics reporting system. Received training in Lean and Six Sigma, responsible for the continual application of such principles. Worked with the Engineering department on project “InLine” which reduced work in process (WIP) and increase throughput and turnaround time. Assisted Quality Engineering Department and Management in root cause investigations, out of specification investigations, out of trend investigations, and changes to controlled manufacturing documents. Elected Chair of the Intern Co-op Association (ICA), have successfully led team members of ICA in fundraising, awareness, and educational events. Worked with ICA group on Materials Flow Project, part of FMEA project to incorporate manufacturing of an additional product to the Raritan plant.

Assisted in all areas of capital project management, including: scope development, cost estimation and monitoring, communication, execution and controlling, and completion.Ensure all activities performed complied with all Schering Plough standards, FDA GxPs and OSHA standards.Reported on site energy usage and made energy studies to aid in the reduction of energy usage and cost. Established more transparent and accurate metrics system that increased the amount of information reported to principle engineer and reduced the query and data entry times. Developed effective training and reference resources for preceding co-ops and interns consisting of detailed instructions of all responsibilities, and a consolidated reference with important plant information.

Responsible for the progress of several schools, mentors assigned to them, and training of new mentors.Assisted high school students with manufacturing and designing custom robots.Provided guidance to students on safe and proper use of machine shop tools, such as drill mills, drill presses, lathes power saws, and hand held power tools.Assisted grammar school students with building and programming LEGO MINDSTORM robots.Developed students’ understanding of elementary physics and computer programming.