• Directed Quality Control department and site testing programs to support manufacturing production schedules, including testing of incoming materials, in-process materials, and final commercial product• Established a Quality Control laboratory from the ground up with associated procedures for material and sample management, routine testing, general lab practices, equipment calibration and maintenance, and environmental monitoring strategy• Demonstrated compliance of QMS with ISO 13485:2016 standard culminating in certification

• Directed the Calibration and Rotor QC teams to meet production requirements and improve the overall efficiencies across manufacturing processes site-wide for reagent and rotor manufacturing• Facilitated >50% reduction in waste in key manufacturing and QC testing processes by applying Lean principles and continuous improvement tools• Yellow belt certified; Green belt certification and project in progress

• Coordinated process optimization efforts for calibration and reagent manufacturing teams to enhance cGMP compliance and identify process improvements• Reviewed non-conformances and material investigations presented at site MRB to facilitate efficient product disposition through a combined technical and quality-focused perspective• Administered operations projects and investigations to support on-time product manufacture

• Managed operational and technical aspects for on-market molecular controls product line, including formulations and quality control teams• Interfaced with customers to troubleshoot complaints• Administered manufacturing and event investigations prompted by both complaints and non-conformances for root cause analysis and identification of corrective and preventative actions

• Planned and executed studies supporting immunoassay development of therapeutic drug monitoring (TDM) and drugs of abuse testing (DAT) products• Authored amendments to SOPs optimizing data collection workflows and controlling for sample carry-over contamination of instrument probes

• Designed and executed studies focused on verification and validation of proprietary devices and methods intended for blood collection and testing for chemistry analytes• Promoted to Sr. Scientist for making significant contributions toward improving accuracy and robustness of select clinical protocols utilized for diagnostic testing of customer blood samples• Supervised small teams of scientists and research associates tasked with carrying out sample preparation and processing protocols at interface of R&D and CLIA laboratories

• Monitored device and process performance for select clinical protocols in real-time utilizing multiple data sourced from patient testing, device QC, and on-going daily studies• Created Excel and R scripts to automate and enhance data analysis and trend visualization• Contributed to authoring regulatory filings for medical devices and assays, e.g. FDA 510(k)