Results-oriented Quality Engineer known as a consistent team player with skilled technical abilities; extensive electronic/electrical and mechanical experience within both manufacturing and testing laboratory environments. Fully knowledgeable of International, Domestic and Regulatory Standards and directives (Medical Device Directive and EN60601) relating to product safety and ISO13485:2003 as well as CFR 820. Conscientious, highly motivated individual capable of working independently and as a member of an integrated team.
Senior Quality Engineer (Contractor)
May 2011 – April 2012
GeNO, LLC Cocoa Florida 32926
Medical Device/Pharma Manufacturer
Responsible for working closely with R&D in the development of Design History Files for the FDA submission of two combination products to the FDA. One device was submitted on a 510(k) the other was submitted as a New Drug Application (505b2).
Advised R&D on Regulatory, Safety and EMI/EMC requirements. Qualified major contract manufacturer as a supplier of the finished devices. Wrote component specifications for all critical and off the shelf components. Responsible for the Design History File; Design input, Design output, Design Reviews, Design verification and validation (software and electro-mechanical), Design transfer and Design changes.
Senior Quality Systems Engineer
September 2007 – April 2011
MC Assembly Inc., Palm Bay Florida
Electronics Contract Manufacturer
• Responsible for developing and obtaining ISO 13485:2003 and AS9100B registrations for the Palm Bay facility and the Fresnillo, Mexico facility.
• Liaising with various medical device manufacturers concerning regulatory and standards issues.
• Maintaining Device History Records for customers.
• Liaising with standards companies such as UL, CSA, and ETL.
• Regulatory Affairs including FDA Part 820, FAA Part 21 (Repair Station) and ITAR.
Quality Engineering Lead
October 2006 – September 2007
LungRx, Inc. Melbourne Florida
• LungRx, Is a wholly owned subsidiary of United Therapeutics Corporation, Silver Spring MD.
• Responsible for the development and registration of the company’s quality system to ISO 13485:2003.
• Assisted in the development of an oral nebulizer for the administration of the drug Treprostinil to aid patients suffering from pulmonary arterial hypertension (PAH).
• Worked closely with a contract design/manufacturing company in the submission and approval to IEC 60601 through Underwriters Laboratories Inc.
• Developed user’s manual for the Nebulizer.
• Assisted in the New Drug Application (NDA) submission for a combination product (drug and nebulizer) to the FDA.
• Developed drug labeling protocol for packaging.
February 2006 – October 2006
Perry Baromedical Corp, Riviera Beach Florida
• Perry Baromedical is a manufacturer/developer of hyperbaric chambers.
• Responsible for maintaining the current registered ISO 13485:2003 Quality System.
• Interfaces with all external safety and regulatory organizations; FDA, CSA, ASME.
• Projects included creating FDA 510(k) submission for updated hyperbaric chamber and rewriting ASME Quality Manual for Pressure Vessels for Human Occupancy.
Quality Engineer – Medical Devices
November 2005 – January 2006
MC Assembly and Test, Incorporated, Palm Bay Florida
• MC Assembly is a national leader in the contract manufacturing industry.
• Providing turnkey solutions to the original equipment manufacturer that can reduce cost, increase quality, and maintain product availability.
• Responsible for maintaining and improving the Registered ISO 9001:2000 Quality System.
• Functioning as company consultant in all matters concerning the Food and Drug Administration; Registration, Listing, and Validation and Verification of processes, Underwriters Laboratories and various other national and international safety organizations.
• Instrumental in training the production and supervision staff on RoHS (Restriction of Hazardous Substances).
• Performed daily Quality Engineering functions such as; Corrective and Preventive Action, Returned Merchandise, Deviations, New Product Introduction, Receiving, and In process and Final Inspection.
Manager Quality Assurance and Regulatory Affairs (Start-up)
April 2003 – November 2005
NUVO/Cybersonics, Incorporated, Erie, Pennsylvania
• Manufacturer and developer of Surgical lighting, Video Monitor systems, Lithotripsy equipment and Cardiac Canalization equipment, Manufacturers Representative ISO13485, FDA Correspondent, UL/CSA, MDD, EMC advisor.
• Responsible for implementing the (ISO13485, QSR, CFR 820) Quality System.
• Maintaining FDA Registration and Listings, including writing and submitting the FDA 510(k) for the lithotripsy system.
• Additionally responsible for Product Safety Engineering.
• Working closely with Development Engineering (IEC 60601) and submitting products for Listing/Certification to Underwriters Laboratories Inc. and the Canadian Standards Association.
Quality Systems Engineer
June 1998 - April 2003
ACU-RITE Incorporated, Jamestown, New York
• Manufacturer of optical encoders and digital readout systems for the machine tool industry.
• Responsible for the company’s ISO9001 Quality System.
• Team Leader directing the revitalization of the Supplier Quality Assurance Team.
• Main contact and liaison for ISO Registrar.
• Completed the update of the Quality Manual to conform to ISO9001:2000.
Regulatory /Standards Quality Engineer
May 1987 - March 1998
LEICA, INC., Optical Products Division, Buffalo, New York
• International manufacturer of microscopes, refractometers, and diagnostic medical instruments.
• Responsible for the company’s standards/regulatory and product safety affairs.
• Official Correspondent to the Food and Drug Administration.
• Successfully prepared, submitted and maintained 510(k) applications for In vitro Diagnostic Devices class 1
• and 2; including Hemicytometers, Bilirubinometers, T/S Meters, Refractometers, Non-Contact Tonometers, Colony Counters, Compound and Stereo Microscopes and Accessories.
• Maintained all Device listings, and Establishment Listings for various sites, maintained Quality System Manual; developed and maintained electronic customer complaint system.
• Responsible for product/package marking, primary member of a Beta site for Clinical Test and lead member of the Product Recall Team, contact person for Department of Defense Quality Assurance Representative.
• Responsible for interpreting D.O.D and F.D.A. contracts.
• Secured Underwriters Laboratories (UL) listings for the Optical Products Division’s products from conception through product life cycle. Worked closely with Research and Development, and Manufacturing Engineering to ensure compliance with product safety standards, PPAP, FMEA requirements. Functioned as one of the architects in developing Leica’s ISO 9001 Quality Manual, writing procedures and selecting the Registrar. Additionally responsible for the Material Review Board and Calibration.
• Responsible for receiving inspection, in process inspection and final inspection, calibration, supplier qualification and supplier surveillance.
• Assumed responsibility for redeveloping and upgrading existing electrical and electronic products to comply with European standards.
• Realized cost savings in excess of $250,000 in materials and manpower, resulting in the simplification of assembly processes.
• The company is now eligible to certify all electronic/electrical products with the CE mark, and many products bear the highly regarded VDE mark.
• Managed a section of the Quality Organization known as Returned Merchandise.
• Responsible for four individuals that handled the day-to-day operations of that department to include; Shipping, Receiving, Inspection and Clerical.
• Responsible for Customer Complaints.
• Responsibilities included interfacing with and satisfying customers that included Medical Doctors, Nurses, Scientists and the full range of the public.
• Responsible for making sure warranty repairs were returned or replaced to the customer within five days.
• Responsible for the processing of all credit returns.
Education and Training
• Certificate, ISO 13485:2003 Internal Auditor, TUV
• Certificate, FDA QSIT Program
• Certificate, CE Marking, BSI
• Certificate, Microsoft Access 2.0, levels 1, 2, 3, and Developer, Ikon Business Solutions
• Certificate, Laboratory Equipment UL 3101 and CE Marking Strategies for European Compliance Underwriters Laboratories, Inc.
• Certificate, ISO 9000 Auditor Training, State University of New York at Buffalo
• Certificate, Managing Total Quality, 3M Company (8D technique)
• Certificate, Excellence Training for Supervisors, Xerox Corporation
• FDA Good Manufacturing Practice Courses, Food and Drug Administration
• Electrical Technology and Technical Writing Courses, Erie Community College
• Signal School, Electronics, GCA Repair, United States Army, (Military equivalent to AAS)
• Diploma, Bishop Neumann High School
• Proficient in the use of Windows, Word, Microsoft Access, and Excel