Laura I Boyd
605 Saturn Drive, Effort PA 18330
Cell 5702361905 Email laurab324@verizon.net
Seventeen years of Quality Assurance applications and writing full quality systems, plus over 7
years regulatory knowledge and implementation of GMP, FDA QSR, JPAL, CQC, ISO, CAMDCAS,
MDD and CE applications to disposable and diagnostic medical devices, R& D devices, packaging and
over 10 years experiences in medical device sales. An Internal ISO and Quality System Auditor, performs
risk analysis on new and established product developments. Knowledgeable in FDA submissions and
experienced in interacting and handling FDA and other domestic and international audits. An authoritative
self motivated individual that is experienced in planning and conducting structured meetings.
Additionally, have special skills in international business and clinical data collection.
Quality Assurance Manager
August 2008 to October 2010 Imaging Sciences International LLC (Danaher Corp) – Hatfield, PA

Responsible for hiring and managing Complaint Coordinators, Quality Engineer, Document
Control, Quality Inspectors and QA technicians for the Quality department.

Responsible for maintaining quality system procedures and processes and making improvements
to the system.
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Achieved merging 2D & 3D Imaging Quality Systems to re-cert ISO/CMDCAS/EC certification
June 2010 under one notified body/ registrar.

Ran chartered Kaizen event to implement Incoming Receiving to meet regulatory requirements. As
well as participated in Shin Kaizen event to reduce crating time of devices.

As Management Representative; represented the company in all FDA, ISO, EC, JPAL, CMDCAS,
ETL and international government audits. New certifications achieved: JPAL, CQC, and Romania.

Responsible for ECN review and approvals as well as new product development through tollgate
phases and V&V documentation.

Overseas and manages the Complaint, CAPA, Calibration, Document Control, NCP and Product
Hold programs.

Responsible for conducting Management review and Product Surveillance Committee providing
trending on collected data.

Responsible for monthly trending of software & hardware complaints, audits, ECN, NCP, and
suppliers.

Represented Quality in regular cross functional meetings for solving software and hardware issues
and developing quality plans for new product development.

Participated in change of ERP system from Oracle to SAP to include moving customer complaints
in SAP.

Applications frequently used; Master Control: document repository, CAPA, training. As well as
Microsoft excel, & word.

Responsible for training where appropriate and maintaining the QA/RA training matrix.
Quality Manager
June 2006 to December 2007 GlucoLight Corporation- Bethlehem, PA
 Writing and implementing the entire Quality System for non invasive medical monitoring devices using Optical
Coherence Tomography with US FDA QSR, ISO 14971, IEC 60601

Risk Analysis ISO 14971; Project leader – conducting FMEA study meetings.
Laura I Boyd
605 Saturn Drive, Effort PA 18330
Cell 5702361905 Email laurab324@verizon.net

Managed and trained personnel on quality system activities and maintained all training records.

Responsible for all device labeling; label control system implementation and device storage.

Responsible for facilities lab and manufacturing controls, identification controls.

Acting safety officer, monitoring safety to patient’s privacy during clinical studies.

Conversion CRF’s data collected and applied data conversions of glucose per study.

Review of CRF’s, Clinical Protocols, Non significant Risks, Investigators Brochure, IFU and label controls to
include identification and traceablilty serial numbers and batches of all devices and clinical studies run on each
device.

Responsible for writing, implementing and maintaining MDR and DHR and batch files as well as securing
clinical data electronically.

Document control duties; responsible for approving all documentation throughout the Quality System and
clinical documentation, routing, revising and maintaining proper revisions manually and electronically on main
network server.

Implementing and maintaining the tools and equipment used to include its calibration records.

Responsible for implementing and maintaining a supplier lists and BOMs of all incoming components and
parts. Controlled all receiving record activity and performed inspection, testing and proper storage.

Responsible for writing, implementing and maintaining the CAR and SCAR system and records.

Responsible for implementing and maintaining an effective RGA system for all devices used in clinical studies.
ISO Manager/ Quality Assurance Manager/ International Marketing Representative
August 1989- October 2005 Viscot Industries Inc. /Viscot Medical LLC- East Hanover, NJ

Writing and implementing the Quality System for class I sterile Medical Devices with US FDA QSR, ISO
9002:1996 upgrades EN46002, ISO 13488, ISO 13485, CE marking, CAMDCAS and Risk Management.

ISO Management Representative; assigning of process Owners

Certified Internal Quality System Auditor; performing continual assessments, handled all FDA, domestic ISO
and International audits.
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Maintaining batch history records.
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Controller of all Documentation, Quality Records, & Management Review Meetings

Post Marketing Surveillance and & supplier surveying
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Supplier resource and storage controls

Kaizen and Lean manufacturing- reduction of waste to meet quality objectives.

Project leader-conducting FMEA studies

Implementation of Design Control, MDR & Technical files, Label and literature control
Laura I Boyd
605 Saturn Drive, Effort PA 18330
Cell 5702361905 Email laurab324@verizon.net

Performed Quality Assurance duties, Inspection and testing, handling of CARS and SCARS, calibration of tools
and maintenance inspections.

Validation Protocols for Class I sterile Devices, verification review of bioburdens for sterility testing.

Maintaining a Class 100,000 Clean room and controlled environments

Performed Incoming, In-process, and Final Inspection of components, raw goods and products

Sales & Marketing Overseas and US of medical disposable to include handling overseas shipping documents.

Domestic and Overseas conventions & trade shows: US Embassy London, England 11/91 US Department of
Commerce trade meeting. AORN conventions 89’ through 1994
Education

Six Sigma Green Belt , Villanova University 2/06 -3/06

M.B.A.IB, Masters in Business Administration with International Business- Johnson & Wales University,
Providence, RI: Graduation 11/93

BS Food Service Management-Johnson &Wales University, Providence, RI: Graduation 5/89

A.O.S. Culinary Arts-Johnson & Wales University, Providence, RI: Graduation 5/87
Professional Experiences & Specialty Training
 Responsible for setting up entire Quality System of ISO 9002 and EN46002 in 1 year time span receiving
certification for Medical Device Manufacturer September 2000. In Addition implemented MDD 93/42/EEC to
CE mark Sterile pen marker Products receiving certification October 2002. Certifying the company to ISO
brought the in additional $500,000 in sales. Responsible for ISO 13488:1996 & ISO 13485:2003 upgrades.
 Seminar Compliance on Line- “The U.S. FDA Medical Device Approval Process” FDA 510K submissions,
PMA and IDE course study. April 2008.
 Clinivation seminar 4-26-07 IEC 60601 update on revised Medical Electrical Equipment
 Clinivation seminar 6-28-07 Safety & Risk update ISO 14971
 Overview training of ISO 14971 Risk management provided by BSI. Risk Analysis Engineering applications
such as FMEA method applied Medical Devices. Managed and conducted FMEA studies and meetings.
 ISO 13485:2003 Awareness Training provided by BSI. Applied Process approach to Quality System through
flow chart demonstrating.
 Marketing skills that has created long-term business relationships with J&J bringing in over $300,000 yearly
plus other long-term relationships with well-known hospitals; such as Massachusetts General and Yale
University Hospital to coordinate new products.
 International marketing to include long term business relations with Japan, Germany, Australia, New Zealand,
Spain, Switzerland, Canada, and United Kingdom.
Laura I Boyd
605 Saturn Drive, Effort PA 18330
Cell 5702361905 Email laurab324@verizon.net
 Match Maker meeting US embassy London England
 Conventions Across the USA for AORN (Association operating Room Nurses) and National Plastic Surgery
 Notary Public- Monroe County PA. Notary Commission 9-07-2006 through 09-07-2010 PAN Member; Certificates
Basic and Advanced Notary training.