Nicholas Tilghman Email & Phone Number

United States

Salt Lake City, Utah, United States

Updated global complaint policy and trainingReworked company complaint handling procedure (~200+ hours saved per month)Validated in-house digitization of DHR record keeping (6-Figure savings)SME and trainer on internal quality metric toolsGlobal customer complaint handlingCAPA TeamAudit Team

Salt Lake City, Utah, United States

SME Sterilization and Packaging Validation (Brain Implant)Managed Product Metrics (Bioburden, BET, RPT, and EO Residual)Managed Cleanroom Metrics (Microbial, Airflow, Particulate concentration, and ISO class)Final Product InspectionMDSAP Audit TeamSupplier QualityInternal AuditsCAPA TeamRegulatory SubmissionsCorporate Games- Ultimate Frisbee (2nd Place)

Greater Salt Lake City Area

• Maintained quality documentation for first ever Aortic polymer heart valve and all patients in FDA study and study expansion.• Owned document control, sterilization, and operating room inventory of first ever Mitral polymer heart valve implantation in FDA study.• Digitized and organized Finished Device documentation to increase release time of finished device batch releases from 5 days to 2.• Reoriented sterilization protocol to increase finished device batch volume by 43%• Took control of inventory management from VP of Operations.• Helped reduced 2020 ISO 13485 audit findings by over 66% from 2019. 2021 No findings.• Evaluated R&D devices and protocols for feasibility.• Own equipment IQ, OQ, PQ, PM, and calibration in QMS.• Fill in for Hydrodynamic Department daily operations as needed.• Fill in for Manufacturing Department packaging medical devices as needed.

Greater Salt Lake City Area

• Assisted team in managing the validation of two new facilities.• Validation report workload grew +30% in 2018 and +25% in 2019. • Perform DQ, IQ, OQ, and PQ on equipment, systems, and testing methods.• Review ISO/USP/AMEE/ASTM documentation to perform R&D to develop testing protocols.• Focused Steam and EtO BIER sterilization.• Nelson Labs Mentor - Official training course for Mentorship for other colleagues.• Work closely with 21 CFR Part 820 and Part 11/Annex 11.

Beaver, Utah

• 2017 – Lead team to record low customer complaints.• Lead on audits by FDA, Utah Dept. of Agriculture and Food, and SQFI.• Kept certification for SQFI, Halal, Kosher, and State entities.• Created and maintained HACCP, HARPC, sanitation, food security, and environmental plans.• Kept documentation audit ready for customer and governmental audits year-round.• Trained the entire employee base on Federal food safety/quality, sanitation, and environmental compliance.• Perform R&D on food products allowing for 2 new product lines. • Limited employee base - Assist in maintenance, cheese production, and forklift operation.

Hattiesburg, Mississippi Area

• 2016 Achieved highest SQFI score in plant history • 2015 Increased plant SQFI rating from Good to Excellent.• Trained replacement technician while taking over QA&C management roll.

Oak Grove, Ms

National Certified Pharmacy Technician Licence July 2015 (CPhT 2017) • Help manage lab paperwork, and inventory for pharmacy regulatory review.• Worked in clean room making medicated creams and capsules from raw medicinal ingredients.• Performed quality analysis on cream shelf life and capsule weights.

Starkville, Mississippi

• Managed time records for over 200 temporary employees.• Worked 18+ hour shifts - assisting in delegating employee resources.• Coordinated with management team in a constantly changing work environment.

Starkville, Ms

Teaching Assistant• Taught a 3-week course of AutoCAD to ABE-1911: Engineering Life Sciences• Created stock of agars and cell growth plates for graduate research in BSL-II lab• Cleaned laboratory to insure readiness for various graduate research studies Mammalian Placenta Study• Assistant in research results published in the Annals of Biomedical Engineering, October 2012, Volume 40, Issue 10, pp 2255-2265 " Stress State and Strain Rate Dependence of the Human Placenta." • Prepared human and sheep placenta tissues in t-bone stress state and strain rate testing in BSL-II wet lab.• Ran samples through stress and strain rate testing using an Instron machine. Brain Trauma Study • Assisted in research results published in Journal of Biomechanics, November 2014, Volume 47, Issue 15, Pages 3704–3711 " Quantitative analysis of brain microstructure following mild blunt and blast trauma."• Acquired fresh samples of porcine brains for study from the MSU vet school necropsy lab.• Developed a protocol for cell counting using ImageJ used by the ABE department.• Studied and applied rolling average algorithms to reduce noise in high speed impact testing.