JAMES FRANKS
Palm Beach Gardens, FL *****
**********@*****.*** 561-***-**** LinkedIn.com/in/james-franks/
MEDICAL DEVICE SPECIALIST
Accomplished professional with 12 years of experience in medical devices and product training. Wide-ranging knowledge of operating procedures and work instructions. Challenge-driven and extremely motivated; accurate and precise with meticulous attention to detail. Organized and efficient, able to work independently and prioritize with little supervision. Areas of expertise include:
•Central Service Technician Experience
•Project Deliverables
•Technical Troubleshooting & Problem Solving
•Cross-function Communication
•Complaint Files - 21CFR 820.198
•Blueprint Reading (Isometric Projection)
•IFU (Instructions For Use)
•Operating Room Experience
•Record Inspection Verification
•Medical Device Reporting - 21 CFR Part 803
•Regulatory Reporting Determination
•Severity / Harm Assessment
•Quality Control Inspection
•Measurement Instruments
PROFESSIONAL EXPERIENCE
DEPUY SYNTHES POWER TOOLS (PREVIOUSLY THE ANSPACH EFFORT, INC.), PBG, Florida 2006 – 2018
Offers comprehensive range of air, electric, and battery driven high and low speed instrument systems, reamers, and saws to meet clinical needs for orthopaedics, traumatology, neurosurgery, neurotology, spinal procedures, otolaryngology, and cranio-facial surgery.
Customer Quality, Complaint Specialist (2014 – 2018)
Interfaced with healthcare professional customers for reporting of complaint and adverse events. Conveyed positive image of company to ensure customer satisfaction. Supported Sales team with highly technical data and product expertise.
Delivered and participated in ongoing product training, which led to improved content coding of product complaint records.
•Managed complaint records ensuring files were investigated, completed, and closed files in accordance to established guidelines, consistently meeting required timelines. Processed 3.2K complaint records from open to close including the completion of 2.8K device history reviews.
•Performed device history record reviews for assigned product complaints. Consistently provided thorough and detailed service and repair information ensuring effective investigation of complaint devices.
•Ensured complaint content accuracy by acting as key resource to explain medical terminology and abbreviations contained in complaint reports received from Hospitals and Medical Professionals.
•Monitored customer complaint data for product quality trends and informed management of potential safety issues.
•Completed compliance program-related activities as required.
DEPUY SYNTHES POWER TOOLS (PREVIOUSLY THE ANSPACH EFFORT, INC.), PBG, Florida
Laboratory Technician, Professional Education (2007 – 2014)
Executed planning process, delivery and implementation of disposable bone dissection tools and capital equipment for all internal and external Power Tool clinical simulation symposiums. Developed relationships with key stakeholders, surgeons and nursing staff.
Partnered with sales consultants and healthcare professionals regarding the substitution of disposable and capital equipment inventory resulting in numerous successful clinical simulations and saving company over $250K.
Received Platinum Star Award in May 2014 when shipping hold was lifted, and distribution of disposable inventory fully resumed.
Executed professional education calendar regarding shipping and receiving of demonstration materials for all internal and external extension site educational programs.
Partnered with Product Development on a continual basis providing surgeon and OR staff complaint feedback.
Coordinated and participated in preparation of cadavers, including setting up Power Tools and 3rd party medical instrumentation for clinical simulations.
•Ensured quality checking, refurbishing, and the tracking of demonstration materials after educational programs were completed and the devices had returned in-house.
•Meticulously decontaminated and sterilized surgical instrumentation, per company products IFU (Instructions For Use), which ensured more surgery-ready sets for clinical simulations and reduced repair costs. Recognized by service staff for consistency and reliability.
•Responsible for usage history or inventory stock items and determined ordering requirements. Prepared purchase orders and verified specifications of purchase orders.
•Maintained additional in-house laboratory equipment such as dissection instrumentation, endoscopes, microscopes, overhead lights, and suction machines.
•Assisted in clinical simulations by delivering access instrumentation, power tools, and performing any other tasks directed by surgeon, which resulted in seamless presentations.
DEPUY SYNTHES POWER TOOLS (PREVIOUSLY THE ANSPACH EFFORT, INC.), PBG, Florida
Shipping Coordinator, Distribution (2006 – 2007)
Examined and inspected stock items for defects, reporting any damage to supervisors.
EDUCATION AND PROFESSIONAL DEVELOPMENT
•Certificate of Completion, Certified Registered Central Service Technician (CRCST), IAHCSMM, Purdue University, West Lafayette, IN
•Coursework towards Bachelors of Science, Palm Beach State College, Palm Beach Gardens, FL
•Diploma, Dublin College Preparatory Academy, Dublin, NH
•Six Sigma Green Belt Certification, 2017
•Basic Life Support - BLS, National CPR Foundation, 2018 – 2020
•Bloodborne Pathogens, National CPR Foundation, 2018 – 2020
TECHNICAL SKILLS
EtQ Reliance, SalesForce.com, SAP, JDE Synthes AS400, Document Locator, Microsoft Office Suite: MS Office, MS Excel, MS Outlook
ASSOCIATIONS
Member, American Society for Quality (ASQ)