Kyle Schepis Email & Phone Number

Brooklyn, New York, United States

Successfully developed and enhanced the package integrity test program, outsourcing testing to third-party labs.Led the design and execution of stability studies, establishing shelf life claims and optimal storage conditions.Spearheaded multiple design verification projects, contributing to 510(k) submissions and product approvals.Developed and maintained a semi-automatic labeling machine, achieving a reduction in labor costs while increasing production capacity.Led the transition from 100% to AQL inspection, saving labor costs during manufacturing scale-up.Unified sampling plans across incoming material and final product inspections, enhancing quality control processes.Supported equipment qualification during manufacturing scale-up and cGMP improvements.Designed and implemented a custom test apparatus for design verification testing.

Brooklyn, New York, United States

Led design FMEA for the company’s first human productParticipated in hazard analysis and process FMEA risk assessmentsProposed and executed design verification studies, including container closure integrity tests per ISO 11607 and stability studiesPerformed measure systems analysis (MSA) studies on container closure test equipmentInvestigated packaging defects and proposed CAPAs to reduce the defect rateReviewed batch records, disposition records, and equipment calibrations.

Brooklyn, New York, United States

Improved quality systems, such as nonconformance and training, with risk-based modelsReported, Investigated, and Reviewed non-conformances, CAPAs, and change requestsRevised final inspection process to standardize inspection criteria and reduce defectsPerformed gap assessments for ISO 13485 and 21 CFR 820Reviewed batch records, disposition records, and equipment calibrations.

Brooklyn, New York

Design and implement quality management systems (QMS) in SharePoint and PowerBIAutomate QMS processes with Microsoft FlowAnalyze and Present QMS data in user-friendly reports using PowerBI to demonstrate progress in Key Performance IndicatorsPresent ideas and projects in company-wide meetings