Medical device Quality Engineer

Highly skilled, experienced Biomedical Quality Engineer: Part-time Contract Consultant in all aspects of Quality functions & Risk Management, supporting design engineering/design control development, implementation, and remediation of Class II and Class III devices in compliance with FDA & international (ISO 13485) device regulations.

Medical device reviewer at FDA.Certified Northrop Grumman ISO 9001/AS9100 Internal Auditor.

Skilled in QSR (820), EU (ISO 13485), and ISO 9001/AS9100 requirements, Design Controls, SOP/Work Instruction development, Design History File maintenance, gap analysis and remediation, specifications, protocols, Verification & Validation testing, Supplier Quality/Vendor Assessment, CAPA process, investigations & remediation, GMP, Safety & Effectiveness testing, internal auditing and mitigation, Risk Management/ FMEA (ISO 14971), complaints/failure analysis, product improvement.

Areas of Expertise/Core Competencies

Quality Engineering, Regulatory and Compliance

Product Improvement

Risk Management (e.g. DFMEA, PFMEA, FTA)

Corrective and Preventive Actions (CAPA)

SOP, protocols & reports, change management

Complaint investigations & root cause analysis

Creating and maintaining Design History Files

Biocompatibility & Human Factors testing

Verification/Validation testing, Supplier Quality

Internal auditing and remediation

Compliance with 21 CFR 820 & ISO 13485

Managing tasks & projects to meet timelines

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

Manage and support Quality Management System, validations, complaints, nonconformances, audits, preventive maintenance, Manufacturing Operations, CAPAs, DCRs, SOPs, FMEAs, stability studies.

OPGEN, Gaithersburg, MD Staff Quality Engineer 2018 – 2022

Manage and support Quality Management System, Risk Mgt, and Regulatory support for an in-vitro diagnostic device system for the rapid detection, identification, and recommended treatment for antibiotic resistant bacterial infections, which obtained FDA 510(k) Clearance.

MICROAIRE, Charlottesville, VA Quality Engineer Contract Consultant 2017 - 2018

Medical device Design History Files (DHF) Remediation/Risk Mgt and New Product Development of an endoscopic carpal tunnel release (ECTR) system and a power-assisted liposuction (PAL) system

NORTHROP GRUMMAN, Elkridge, MD 2015 - 2017

Mission Assurance [Quality] Engineer for the development of a Biodosimetry in-vitro diagnostic device for the quantitation of radiation exposure and a Biohazard Detection System for the US Postal Service.

21CFR820 Design Controls, Design History Files, Supplier Quality, Internal Auditor, documention

Approved Northrop Grumman Internal Auditor for ISO 9001:2008 with AS9100C/AS9100D Transition

PROJECT CONTRACT CONSULTANT POSITIONS

MAQUET, Wayne, NJ- Supplier Quality Engineering: remediation of supplier process validation, supplier quality CAPAs and audit findings, authored overall Supplier Quality Management SOP.

COGNIZANT TECHNICAL SOLUTIONS, Raritan, NJ- Manager, Validation Compliance – assigned to J&J-IT: Develop/review System Development Life Cycle deliverables, QA/Validation plans, audit support.

DEPUY SYNTHES/J&J, West Chester, PA, Quality Consultant: Global Compliance Remediation Program- implant devices. Remediation of medical device Design History File.

VALEANT PHARMACEUTICALS, Bridgewater, NJ, Senior Project Manager: Medical device Sr Quality Engineer for Class III device, develop, remediate and update EU Technical File, ISO 13485 Audit remediation.

BRAINSCOPE Company Inc., Bethesda, MD 2012 – 2013

Successfully assisted this company to obtain FDA de Novo and EU ISO 13485 approvals for a Traumatic Brain Injury in-vitro diagnostic device.

Quality Engineer

Authored and contributed to comprehensive overall improved Quality System for a handheld, software driven, EEG diagnostic device. Ensured company & team compliance with all portions of Design Control process and related Compliance/Quality System Regulation/Quality Management System elements:

Product development, SOPs, Verification &Validation, complaints, Corrective and Preventative Action (CAPA), Audit Finding Reports, audit remediation, FDA inspection

Complaints/root cause analysis, design reviews, Risk Management (authored FMEA procedure), Design History File development, remediation & internal audit, FDA submission preparation, mentored staff.

Mitigated and closed open items from QSR and ISO 13485 audits.

FOOD AND DRUG ADMINISTRATION, Silver Spring, MD

2011 – 2012

Biomedical Engineer/Medical Device Lead Reviewer

Completed Medical Device Reviewer Certification Program (RCP) curriculum & passed RCP exam.

Authored and provided reviews of 510(k) premarket submissions (Traditional, Special, Abbreviated).

OTSUKA AMERICA PHARMACEUTICAL Inc., Rockville, MD

2004 – 2011

Senior Device Engineer

Successfully helped move this $8 billion pharmaceutical company into the medical device business.

Managed medical device projects, providing technical development, verification/validation testing, led device complaint investigation/mitigation and FDA Quality System Regulation procedures and documentation. This was accomplished in support of completed U.S. clinical studies of the Adacolumn Apheresis System, a Class III device for Pre-Market Approval (PMA) and commercial market introduction, and for the US-marketed BreathTek in vitro diagnostic device system.

Authored/revised QSR documentation (e.g. CAPA SOP, Work Instructions, and forms) for the successful merger of Meretek, a medical device company, into Otsuka America Pharmaceutical.

Led Technical Operations’ support of BreathTek Infrared Spectrophotometers, in vitro diagnostic radiological devices and accessories.

Performed/documented complaint investigations and on-site root cause analysis of mechanical engineering investigations of device problems, using CAPA process to resolve two product recalls, quickly returning products to profitable $5 million market.

Produced product development documentation for antimicrobial drug/device combination product.

AVENTIS PHARMACEUTICALS, Dermik Labs division, Berwyn, PA

2002 – 2003

Clinical Consultant

Successfully helped move this $17 billion pharmaceutical company into the medical device business

Led technical development of a Class III implantable bioabsorbable restorative device:

Created technical and QSR documentation for FDA submissions of New-Fill, a Class III implant device (Aventis’s first) that led to approvals for an IDE and PMA for two separate indications.

Created device verification and validation test protocols and reports, reducing development time.

Assured adherence to US 21 CFR 820 QSR and (international) ISO 13485 regulations.

KENSEY NASH CORP., Exton, PA 2000 - 2002

A $29 million cardiac catheter and bioabsorbable materials company.

Senior Product Development Engineer

Key contributor to the management, development and approval (U.S. and E.U.) of TriActiv™, a novel cardiac catheter device system providing distal protection from embolization during saphenous vein graft cardiac stent and angioplasty procedures. Specifically:

Created and performed in vitro functional DOE test protocols of devices that led to clinical use.

Directed preclinical animal studies that led to FDA approved clinical studies.

Created device Instructions for Use for physicians that were validated during clinical studies.

ETHICON Inc. (a Johnson & Johnson company), Somerville, NJ

1999 – 2000

Staff Specialist, Corporate Project Management

Supported GYNECARE (women’s health) and MITEK (sports medicine) business units:

Assured adherence to ETHICON’s Global New Product Life Cycle stage gate process, reducing time to market & collaborated with project teams to develop business plans and presentations.

DATASCOPE CORP., Fairfield, NJ

Cardiac device company for intra-aortic balloon catheters and hemostasis device

1988 – 1998

Senior Research and Development Engineer/Project Leader

Performed/documented CAPA, complaint investigations and root cause analysis of intra-aortic balloon catheter device problems, leading to resolution and product improvement.

Developed new medical device products from concept through FDA approvals:

Led cross-functional team for FlexiSheath™ kink resistant catheter introducer, resulting in a 510k.

Led cross-functional team for VasoSeal™ vascular closure device, resulting in an IDE.

Led hemolysis studies for intra-aortic balloon/heart bypass cannulae, resulting in a 510k.

EDUCATION

MS, Bioengineering, Polytechnic Institute of NYU, Brooklyn, NY

BA, 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

Contact this candidate