Danielle K. Email & Phone Number

Princeton, New Jersey, Us

Lead Projects and CAPA Actions to ensure microbiology, sterility and aseptic practices are aligned with AATB (American Association of tissue banks) and 21CFR1271, part 11, EN ISO 13485. Responsible for site wide endotoxin, bioburden, cytotoxicity and glutaraldehyde, microbiological quality control, reaction and continuous improvement. Author of EMPQ, Eto , e-beam and gamma sterilization; annual requalification, protocols, reports and quarterly dose audit review and release.

Boca Raton, Florida, Us

Management Representative/ QMS and 510k remediation. IORT Radiation Class II Medical Device and therapeutics, US/OUS Start UpClass II, SaMD, Cloud NMD, IRB/IDE interoperability medical devices.Innovative in building processes, infrastructure and teams for acollaborative cost-effective concept to production Start Up support. Company Lead for allExternal Audits;FDA, MDSAP, ISO, IPC, Intertek Strategic Implementation of compliant21CFR820 QMS, Internal Audits and bi-annual Management Review Lay off due to Funding Reduction in Force

Minneapolis, Mn, Us

Combo Med Device, Pharma and embedded semiconductors for the pharmaceutical delivery system utilizing algorithms for insulin management of Diabetes.

Clinton Township, Michigan, Us

MIL/Aero, Automotive and Medical Device QMS Implementation Leader, Supplier Quality Auditor, Manufacturing improvements and FDA Remediation: Class I, II, IIb, and Pharma Combo Medical Devices.

Mil/Aero, Med Device and specialty Pharma Mid Sized Company w CMO Internationally- COVID Supply Chain Disruption led to IP sale & layoff 9/21Executive Leadership and Hands on Engineer, for Mid- Sized Company with 5 Global Contract Manufacturers Class I, II, III devices. Technology Transfer to China, Israel, India, MexicoLead Auditor and Management Representative SME: FDA 21CFR 820 and Part: QSIT Regulations, AS9100, ITAF 19649, ISO 9001, 13485, 14971Hands on quarterly travel to our Global Contract Manufacturing partners to support CAPA, CAR, SCAR, NCR, DFSSValidationAuthor, Responsible for creation, review and approval of CMO and OEM manufacturing partners. Direct reports: 15 QE, 36 QC and 239 Operators in India, China, Israel, & MexicoR& D for Lead-acid and Lithium Iron Phosphate batteries, Intravenous therapy, Infusion and accessories; catheters, IV extension sets• Executive strategist: KPI, ROI, COO forecasts, finance, supply chain and distribution• Regulatory File Update Author for EUMDD to EU MDR, CE, Canada SOR/98-282, EEC 93/42, QMS Site Administrator- Lead successful FDA Audits post remediation with Zero Findings. • ISO Lead Auditor:• Global Supplier Quality Auditor and Customer Mentor for QMS remediation • Action Audits for Current and New Suppliers (FDA, EU, CE, ISO):• Estill Internal Audits and bi-annual Management Review Author• FDA 483 Regulatory remediation (11 483 and 5 UTL) and Global Recall Coordinator • Monthly submission file updates, open FDA 483, UTL and Recall• Design and validation 510K Remediation, Regulatory Files Submission• Implementation Quality System • Post Market Surveillance; performance, efficacy and safety remediation.• Complaint and MDR Investigation and Failure Analysis:• Investigation and troubleshooting, CAPA, corrective action, defect studies, controlCharts, remediation of 5 circuits: DMM, TI, Zilog microcontroller, thermostats • UDI, GUDID Implementation, application of ID number to existing products

Hired as temp in December 2012, converted to Full-time employee March 2013. Laid off due to company wide layoff May 2014.Quality Production Support, IQ/OQ/PQ/PPQ, MVP, QP, Test method validations, Transfer and New Product Qualifications. Auto-Test mentor to QEII engineers, technicians and operators.Electrical, mechanical, material, chemical and environmental, failure and root cause analysis and implementation of correction/corrective action - CAR/CAPA. Six Sigma and continuos improvement mentor to technicians and operators in Yellow and Green Belt training.

Mil/Aero, Med Device and Pharmaceutical Quality, Regulatory and R& D Engineering Consultant Minimal Business since Covid.Part time and full-time research development and field applications engineering for a Texas Instruments Triquint Semiconductor and Hatco corporation, Oct 2006- September 2011. Pharmaceutical and Biomedical engineering from 2011 to 2021.Underwater engineering consultant and commercial diver, contracted with the Army Corps of Engineers for irrigation dams tributary‘s across the state of Texas and Oklahoma. October 2006 to present part time - no work since Covid.

Milwaukee, Wi, Us

Reliability regression, HALT testing, Warranty, life expectancy, accelerated life testing, load studies, corrosion profiles, and Pro Active design of experiment, statistical process control for prototype and pilot phase for new product development.

Abbott Park, Illinois, Us

Responsible for investigations of failing medical instrument components to ensure FDA Compliance and redesign improvements.Six Sigma, DMAIC, CATS, GSR, GQMS, 5 W's, Rubric, Cause/Effect Tree, 8D, FMEA, DOE: MiniTab/JMP, defect reduction, process specifications, training and troubleshootingCPR/AED, Primary/Secondary Adult and Child Instructor for the companyDAN/SCUBA Emergency Air, AO2 Instructor

Hillsboro, Or, Us

Gallium arsenide and radio frequency research and development.

Oakland, California, Us

Supervising technician manager for three direct reports and six indirect reports to run the alpha-fetoprotein chromosome mapping and polymerase chain reaction development programs at Kaiser Permanente genetics

Bachelor'S Degree Of Science, Physical Sciences And Chemistry

Associate Of Science - As, Pre-Medicine/Pre-Medical Studies