Quality Assurance/Regulatory Affairs
Resume:
Lawrence J. Milana
Manchester, NH 03104
*.******@***.***
Summary of Qualifications
Follows detailed process steps without deviation in order to assure uniform output
Adheres to practices designed to protect both employees and product from contact and potential contamination, including wearing clean room uniforms
Supports the maintenance, troubleshooting and/or rebuilding of fixturing and equipment used throughout the production process
Have worked with radioactive materials and ensured/promoted security, with the knowledge that all equipment, processes and systems designed for the facility have been done so to guarantee a safe and productive environment
Works within, and ensures adherence to Quality System procedures, work instructions and other quality requirements.
Wide range of experience with FDA license submissions under section 510(k), and compilation/maintenance of corresponding technical files.
Experience in troubleshooting and repairing electrical/electronic devices to component level
Experience with military and commercial technical documentation
Extensive experience using electronic/mechanical measuring devices
Strong communications skills
Strong computer and software skills using MS Excel, Word, Access and internet navigational skills
Able to make difficult decisions in stressful situations in a timely manner
Team First attitude
Self starter/problem solver and capable of achieving superior results with minimal supervision.
Work Experience
2015 to 2015 – State of Florida, Okaloosa County, Water and Sewer Department
Utilities Technician
Install, maintain and repair water taps, water lines, sewer lines, manholes and fire hydrants.
Locate water and wastewater lines for preparing work sites and for outside servicers and contractors to protect County system lines from damage.
Operate vacuum truck and excavation equipment.
Repair water leaks, stoppages, lines, sewers, valves, manhole rings and covers.
Inventory equipment, supplies and materials.
Read blueprints and engineering drawings.
Utilize hand-held manual, air and gas-powered tools and equipment in the performance of duties (i.e., pipe wrenches, pipe cutters, saws, cement mixers, air compressors, tapping machines, pipe threaders).
Address and resolve public inquiries and concerns.
Ensure vehicles and equipment are properly operated and maintained.
Participate in restoring work sites to serviceable condition (i.e., repairing asphalt and concrete, filling holes).
2014 to 2015 – City of Fort Walton Beach, Fort Walton Beach, FL
Water Distribution System Operator I
Assisted with operating and maintaining electric motors, pumps, and valves to regulate flow of raw water into water plant
Added specified amounts of chemicals such as chlorine, ammonia, and lime into water or adjusts automatic devices that admit specified amounts of chemicals into tanks to disinfect, deodorize, and clarify water
Monitored and adjusted controls to regulate flow rates, loss of head pressure and water elevation, and distribution of water
Recorded data such as residual content of chemicals, water turbidity, and water pressure
Performed routine tests in collecting samples to determine water quality and treatment effectiveness
Performed preventive maintenance and repairs on pumps, motors, chemical feed equipment, and other electrical and mechanical equipment
Performed inspections to determine compliance with city ordinances and other laws and regulations concerning cross connection control
Performed testing of backflow prevention devices.
Utilities Service Worker II, 2013-2014
Drove vehicles such as: street sweeper, dump truck, and dump trailer and operated heavy and light equipment
Operated and performed preventative maintenance on various construction equipment included but not limited to hand tools, power tools, tamps, quick cut saws, air hammers, mowers, etc.
Performed heavy manual labor such as digging, lifting, hauling, spraying, etc.
Prepared surfaces for paving and shovels and spreads asphalt
Installed and repaired water, sewer and storm water pipes and structures
Operated cement mixer, set concrete form work, placed, shoveled and finished concrete
2012 to 2013 - Heritage Cycles Harley-Davidson, Fort Walton Beach, FL
Sales Associate
Provided outstanding customer support; led sales of Harley-Davidson motorcycle parts and accessories
Directly impacted success of service department; supplied parts needed to complete work orders
Expertise instrumental in providing in-store, on-line, and telephone customers information/recommendations
Managed inventory requisition and replenishment; ordered merchandise to meet required levels
2011 to 2012 – Ridge-Clay Farm, Troy, AL
Farming Associate
Instrumental in the up-start of a 250 acre farm supplying cotton, peanuts, and live stock
Planned and orchestrated repair and demolition of existing outbuildings and machinery
Constructed established egg hatchery structure; ensured care of chickens to ensure offspring of eggs and chicks
Plowed, fertilized, and irrigated 250 acre property; planted/ maintained fields to produce cotton and peanut crop
2001 to 2011 - Philips Medical, Andover, MA
Regulatory Engineer, 2008 to 2011
Corporate expert on Food and Drug Administration (FDA) requirements; acted as company’s authority having jurisdiction on worldwide regulatory requirements for patient monitoring systems
Monitored regulatory requirements; efforts in quality assurance ensured the maintenance of all manufactured medical devices
Personally accounted for all FDA submissions under section 510(k) and all license submissions to Health Canada (Canadian Ministry of Health) and established/ maintained technical files required for the Philips SureSigns Patient Monitoring product line
Focal point for coordination of worldwide product line clearance and acceptance; resulting in sales in excess of one million dollars (US) annually in Mexico, India, China, Korea, Brazil and the Middle East
Quality Investigator III, 2005 to 2008
Investigated customer patient monitor complaints; ensured timely resolution according to company Quality Assurance Program and FDA guidelines
Initiated and followed through with Corrective and Preventive Action (CAPA) procedures according to company Quality Assurance Program and FDA guidelines
Performed Quality Audits in manufacturing line to ensure compliance to company established Quality System
Production Electronics Technician III, 2001 to 2005
Established, maintained, managed printer test process, test area, and parts inventory
Tested, refurbished, troubleshot, and repaired nuclear medical imaging systems and related software/hardware to component level
Provided technical support to field service engineers worldwide on nuclear imaging systems
Education
Northeastern University, Boston, Massachusetts
Master’s Degree in Regulatory Affairs
Troy State University, Troy, Alabama
Bachelor’s Degree in Management,
Minor in Business Administration
United States Army Signal School, Fort Gordon, GA
Class Honor Graduate
United States Army Basic Electronic School, Fort Jackson, SC
Class Honor Graduate
References
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Transcripts
Furnished upon request.
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