Quality Engineer- Medical Device with experience in all aspects of Quality functions, supporting development, implementation, and remediation of medical device Quality Management Systems, in compliance with FDA & international medical device regulations. Was medical device reviewer at FDA.
Skilled in QSR (820) and EU (ISO 13485) 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, Change Controls, Risk Management/ FMEA (ISO 14971), complaints/failure analysis, product improvement.
Areas of Expertise/Core Competencies
Quality Engineering, Regulatory and Compliance Product Improvement
• Risk assessment development (e.g. FMEA, 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
• IDE, 510(k), PMA, De Novo preparation support • Managing tasks & projects to meet timelines
MAQUET, Getinge Group, Wayne, NJ (Contract Consultant)
Supplier Quality Engineer for Corporate Compliance Remediation program
• Authored overall Supplier Quality Management SOP, Supplier Process Validation SOP, revised “children” Supplier Quality SOPs, Work Instructions, and forms.
• Remediation of Supplier Quality CAPAs and audit findings
• Created, maintained, and held to Supplier Quality Remediation Project Timeline
COGNIZANT TECHNICAL SOLUTIONS, Raritan, NJ (Contract Consultant) 9/2014 – 12/2014
Manager, Validation Compliance – Subject Matter Expert, assigned to J&J-IT
• Develop/review System Development Life Cycle deliverables, QA/Validation plans, audit support, CAPA plan preparation and implementation.
DEPUY SYNTHES/J&J, West Chester, PA (Contract Consultant) 4/2014 – 5/2014
Quality Consultant - Subject Matter Expert /
• Global Compliance Remediation Program- implant devices. Remediation of medical device Design History File. 12/14 – 3/2015
VALEANT PHARMACEUTICALS, Bridgewater, NJ (Contract Consultant) 1/2014 - 4/2014
Senior Project Manager
Medical device Senior Quality Engineer for Class III device.
• Develop, remediate and update EU Technical File, ISO 13485 Audit remediation, update DHF Change Control, assure product compliance & registration in different countries.
BRAINSCOPE Company Inc., Bethesda, MD 10/2012 – 9/2013
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 10/2011 –7/2012
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 6/2004 – 4/2011
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.
• Coordinated completion of project plans with Japanese and E.U. manufacturers, successfully supporting distribution, installation, service and training for company’s core medical devices.
• Produced product development documentation for antimicrobial drug/device combination product.
SURGICAL SPECIALTIES CORP., Reading, PA (Contract Consultant) 2004 (3 mo contract)
Regulatory/Clinical Device Consultant
Guided development and submission to FDA of an IDE for a Class III surgical device application.
AVENTIS PHARMACEUTICALS, Dermik Labs division, Berwyn, PA 9/2002 – 12/2003
Clinical Consultant
Successfully helped move this $17 billion pharmaceutical company into the medical device business
Led technical development of a Class III implantable b...
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