Engineer Quality Assurance
Resume:
Tracy G. Eberly
Minneapolis, MN 55409
*****.******@***.***
Experience: Fang Consulting, Minneapolis, MN (1997-Present)
Regulatory Affairs Consultant
Areas of FDA and USA
Expertise: Submissions: IDE, PMA and PMA Supplements, 30-day Notices, Annual Reports, 510(k) [Traditional, Special & Third Party], Labeling Review, Evaluate ECO’s for RA Impact
The European Union
Design Dossiers, CE Mark Technical Files, Five year re-certifications for Design Dossiers and standards review, Labeling review, Evaluate ECO’s for RA impact
Rest of World (Approval successfully obtained in the following countries)
Canada, Australia, Japan, Mexico, Brazil, South Korea, Taiwan, Thailand, Iran, South Africa, Egypt, Lebanon, Israel, Russia, China
Compliance
IEC 60601 Testing for EU, US, UL, Canada and CB Scheme, EMC/EMI testing, X-Ray emiters, Lasers, Ventilators
Clients: Zimmer Spine, Minneapolis, MN
Tissue Bank Registrations, product development team support, DCO sign-offs, IFU’s, 510(k) and Technical Files.
Xoran, Ann Arbor, Michigan
Complete technical file for X-Ray systems, Review all EU testing; IEC 60601-1, 60601-1-2 (EMI/EMC), 60601-1-3, 60601-2-44, etc.
Johnson & Johnson, West Chester, PA
Technical File for insulin infusion pump
Spectranetics, Colorado Springs, CO
Disposition ECO’s for RA impact, Prepare PMA Supplements.
Hemostasis, LLC, White Bear Lake, MN
Handle all Regulatory activities; 510(k)-K102459, PMA, IDE, Technical Files, OUS submissions, labeling review as well as RA strategy for new products.
Boston Scientific, Maple Grove & Arden Hills, MN
Re-certify existing design dossiers for AIMD products for Europe. Submit 30-Day Manufacturing change notices to FDA. Disposition ECO’s for RA impact.
GE Healthcare; Lawrence, Mass & Salt Lake City, Utah
Prepare Technical files per MDD 93/42/EEC and Canadian submittals.
Medtronic; Fridley, MN
Prepare FDA Annual reports for spinal stimulators and implantable drug pumps.
St. Jude Medical, AF Division; Minnetonka, MN
Prepare PMA supplements and Design Dossier for ablation catheters, 510 (k)’s for steerable catheters. Support design team and production on regulatory tasks.
Greatbatch Medical (Formerly Enpath Medical); Bloomington, MN
Prepare a paper PMA and Design Dossier for steroid eluting leads.
CVRx, Maple Grove, MN (RA)
Prepare an IDE submittal. Review and revise SOP’s and Quality System to ISO 13485 and ISO EN 14971.
Cardiac Science Inc., Minnetonka, MN (Compliance Engineer)
Prepare 510 (k) – (K040438) and international submittals for G3 AED’s in Canada, China, Japan, Australia, Russia, Thailand, etc. Revise all CE Mark technical files. Represent Quality Assurance in FDA and NSAI audits for ISO 13485 and CMDCAS certification.
Lumenis; Santa Clara, CA (Staff Compliance Engineer)
Evaluate current and proposed medical laser designs. Address all issues related to EMC, safety and regulatory compliance, R&D interface with RA and QA, maintain design history files. Responsible for maintaining compliance of products transferred from Santa Clara to Yokneam, Israel and Salt Lake City, UT. Lead person for all audits from ITS and UL; support person for BSI and FDA audits.
Mallinckrodt Inc.; Plymouth, MN (Regulatory Affairs)
Managed all CE Mark technical files for ventilators, apnea monitors, CPAP’s and accessories. Worked with TUV and European distributors. Addressed concerns for Asian, Latin American and Japanese regulatory agencies. Designed and implemented labeling changes to meet international requirements. RA representative for document control project; combined documentation from 3 separate companies.
Microvena Corporation
Test Engineer (April 1996 to April 1997)
Devices: Guidewires, Snares, Atherectomy and Septial Defect; Class II & III
Prepared IDE for atherectomy device and 510(k) for coated guide wires. Managed hydrophilic coating project. Debugged coating processes and verified the feasibility of producing hydrophilic wires. Coordinated production ramp-up schedule to meet projected launch date. Managed project team members from RA, QA, Marketing and Manufacturing. .
Guidant - Cardiac Pacemaker Inc.
Regulatory Affairs and Compliance Engineer (May 1995 to May 1996)
Device: Pacemaker Programmer, FDA Class II
Coordinated all mechanical testing for submittals to national and international regulatory agencies (FDA, UL, CSA, BSI and IEC) for 2901 Pacemaker Programmer. Designed and tested packaging according to ISO 9001 guidelines. Coordinated work with local and national testing laboratories.
Pfizer - American Medical Systems
Test Engineer (April 1994 to May 1995)
Devices: Urological Implants for Incontinence and Impotence, FDA Class III
Coordinated the manufacture and testing of silicon molded and injected parts and new adhesives for the qualification of a new silicone vendor. Managed project resources to meet FDA deadline. Performed PMA testing and cooperated with the FDA on validation of pre-1976 implantable devices.
Boston Scientific – SciMed Life Systems
Sr. R&D Technician, Ancillary R&D (October 1991 to April 1994)
Devices: Balloon, Guide and Diagnostic Catheters, FDA Class II
Designed large lumen guide catheters and diagnostic catheters. Worked on Project Management Team to shorten design to pilot manufacturing cycle. Experienced in extrusion, injection molding, insertion molding, braiding and sterilization. Designed tests for 510 (k) submittals and responses.
Twin City Testing
Mechanical Engineering Technician, Mechanical Test Lab (June 1989 to October 1991)
Perform testing on a variety of products according to established or custom standards and report results to clients.
Education: University of Minnesota, Minneapolis Campus
Bachelor of Science Degree, Multidisciplinary Studies, Engineering and Communication
Interests: Wine Connoisseur, Cigar Aficionado, Home Remodeling Hobbyist, Animation Art Collector
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