Biomedical Quality Assurance Engineer part-time contract consultant

Clifford E. Schwartz

*****************@*****.*** • Takoma Park, MD 20912 • 610-***-****

Summary

Biomedical Quality Assurance Engineer consultant and/or part-time contractor

Detail-oriented and results-driven Medical Device Quality Engineer with extensive experience ensuring compliance with FDA regulations and ISO standards. Proven track record in leading quality assurance initiatives, risk management, and process improvement and collaborating with cross-functional teams. Skilled in developing and implementing robust quality systems, conducting thorough audits, and spearheading corrective and preventive actions (CAPA). Strong analytical skills focused on data-driven decision-making to enhance product quality and safety. Committed to driving continuous improvement and excellence in medical device design, development, and manufacturing processes.

Areas of Emphasis

•Medical Device Quality Engineering

•Quality Function & Risk Management

•Class II and III Medical Devices

•Compliance & FDA regulations

•Quality System Regulation,21CFR Par 820

•Project & Product Management

•21 CFR 820.30 Design Control Processes

•SOP/Work Instruction Development

•International Regulatory Standards (ISO)

•Specifications/Protocol Development

•Leading, Training, Mentoring

•Verification & Validation Testing

•CAPAs, NCRs, Complaints, DCRs, Deviations, Calibrations, PMs

•Gap Analysis & Internal Audit

•Design History Files Management

Career Experience

LGC Clinical Diagnostics, Inc., Gaithersburg, MD 2022 to 2025

Quality Engineer

Oversaw and managed the Quality Management System (QMS), including validations, audits, and compliance with regulatory standards.

Addressed customer complaints and nonconformances, implementing corrective and preventive actions (CAPAs) to enhance quality.

Supported Manufacturing Operations by developing and maintaining Standard Operating Procedures (SOPs) and Deviation and Change Requests (DCRs).

Conducted Failure Mode and Effects Analyses (FMEAs) and stability studies to identify risks and assess product viability proactively.

OPGEN, Gaithersburg, MD 2018 to 2022

Staff Quality Engineer

Managed and supported the Quality Management System, risk management, and regulatory compliance for an in-vitro diagnostic device system that detects, identifies, and recommends treatment for antibiotic-resistant bacterial infections, successfully obtaining FDA 510(k) clearance.

Developed and implemented quality management protocols and conducted risk assessments to identify potential hazards and mitigate risks, ensuring adherence to regulatory standards.

Collaborated with cross-functional teams to prepare, submit, and maintain regulatory documentation for FDA.

Provided ongoing support and training to staff on quality assurance practices, compliance requirements, and regulatory processes.

Microaire, Charlottesville, VA 2017 to 2018

Quality Engineer Contract Consultant - Contract

Conducted remediation of Design History Files (DHF) for the Endoscopic Carpal Tunnel Release (ECTR) system and the Power-Assisted Liposuction (PAL) system, ensuring compliance with regulatory standards and improving overall documentation quality.

Implemented risk management strategies throughout the product development process, identifying and mitigating potential risks associated with both medical devices.

Oversaw the new product development lifecycle for the ECTR and PAL systems, collaborating with cross-functional teams to enhance product design, improve user safety, and achieve successful regulatory submissions.

Northrop Grumman, Elkridge, MD 2015 to 2017

Mission Assurance Quality Engineer

Acted as Mission Assurance [Quality] Engineer for the development of two critical projects:

Biodosimetry in-vitro diagnostic device for quantitation of radiation exposure

Biohazard Detection System for the United States Postal Service

Ensured compliance with quality systems and regulatory requirements throughout the development lifecycle, including adherence to 21CFR820 standards, which encompassed:

Design Controls

Comprehensive Design History Files

Thorough Supplier Quality assessments

Meticulous documentation of processes and results

Served as an approved Northrop Grumman Internal Auditor for ISO 9001:2008 and oversaw the successful transition to AS9100C/AS9100D, reinforcing the organization’s commitment to quality management in aerospace and defense sectors.

Additional Contract Consultant Positions 2013 to 2015

Supplier Quality Engineering Maquet, Wayne, NJ

Manager, Validation Compliance Cognizant Technical Solutions, Raritan, NJ

Quality Consultant, Global Compliance Remediation Depuy Synthes/Johnson & Johnson, West Chester, PA

Senior Project Manager, Medical Device Sr. Quality Engineer Valeant Pharmaceuticals, Bridgewater, NJ

Brainscope Company Inc., Bethesda, MD 2012 to 2013

Quality Engineer

Successfully facilitated the acquisition of FDA de Novo and EU ISO 13485 approvals for a traumatic brain injury in-vitro diagnostic device.

Developed and enhanced an overall Quality System for a handheld, software-driven EEG diagnostic device, ensuring compliance with all aspects of the Design Control process as well as Quality System Regulations and Quality Management System elements.

Managed critical activities such as product development, standard operating procedures (SOPs), verification and validation, complaint handling, corrective and preventive actions (CAPA), audit findings, audit remediation, and FDA inspections.

Conducted thorough complaint investigations and root cause analyses, participated in design reviews, and implemented Risk Management practices by authoring the FMEA procedure.

Oversaw the creation and remediation of the Design History File, conducted internal audits, and prepared FDA submissions while mentoring team members throughout the process.

Addressed and resolved outstanding issues identified during QSR and ISO 13485 audits.

Additional Career Experience

Biomedical Engineer, Medical Device Lead Reviewer Food & Drug Administration (FDA), Silver Spring, MD

Senior Device Engineer Otsuka America Pharmaceuitcal Inc., Rockville, MD

Clinical Consultant Aventis Pharmaceuticals, Dermik Labs Division, Berwyn, PA

Senior Product Development Engineer Kensey Nash Corp., Exton, PA

Staff Specialist, Corporate Project Management Ethicon Inc., (Johnson & Johnson), Somerville, NJ

Senior Research & Development Engineer, Project Leader Datascope Corp., Fairfield, NJ

Biomedical Engineer ElectroCatheter Corp. (Elecath), Rahway, NJ

Clinical Laboratory Technologist, Serology, Microbiology, Hematology Coney Island Hospital, New York City, NY

Education & Professional Development

Masters of Science, Bioengineering Polytechnic Institute of NYC, Brooklyn, NY

Bachelor of Arts, Biology, Pre-med State University of New York, New Paltz, NY

Patents

Bubble Free Connector for Liquid Carrying Medical Tubing, U.S. Patent Nos.: 5312352 and 5439448

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