About this Candidate
DAVRON CV: Candidate 1930142
MEDICAL DEVICE QUALITY ENGINEER | COMPLAINTS, CAPA, REGULATORY COMPLIANCE & NPI
Core Expertise
- End-to-end complaint management and global MDR/MDV reporting across major jurisdictions.
- Leading post-market surveillance, adverse event trending, MAUDE signal detection, and PSUR/PMCF deliverables.
- Failure analysis and root-cause investigations using DFMEA, PFMEA, FTA, Fishbone, and 5-Why.
- NPI quality leadership supporting design transfer, PQP, IQ/OQ/PQ, and Device History Records.
- Built RF/Bluetooth coexistence test capabilities and authored verification protocols for firmware and apps.
Project Background
- Established RF coexistence testing lab from ground up, executing DVT protocols and large dataset analysis.
- Delivered $12M documented cost savings through capital projects and process optimization across manufacturing.
- Owned global complaint lifecycle, performing reportability assessments and timely regulatory submissions.
- Led enterprise PLM migration as SME, authored work instructions, and trained cross-functional users.
- Supervised inspection team, implemented 6S initiative, and achieved a 100% yield improvement.
Key Skills
- 21 CFR Part 820 | ISO 13485 | ISO 14971 | EU MDR 2017/745 | IEC 62304 | IEC 60601
- Complaints & MDR/MDV Reporting | MAUDE | EUDAMED | UDI | FSCA/FSN | Multi-jurisdiction reporting
- CAPA Management | DFMEA | PFMEA | FTA | RCA (5-Why, Fishbone) | SPC
- Bluetooth/RF coexistence testing | Firmware testing | Mobile application validation | IQ/OQ/PQ
- Agile PLM | Jama | ComplianceQuest | Pilgrim SmartSolve | eQMS
- Minitab | Python | Jupyter Notebooks | AutoCAD | Microsoft Office Suite
Education
- M.S., Computer & Information Science — Southern Arkansas University
- B.Eng., Mechanical Engineering — RVR & JC College of Engineering
Awards & Recognition
- Certified Quality Engineer (CQE) candidate (in progress)
Why Interview this Candidate?
A senior medical device quality engineer with 8+ years of regulated-industry experience and proven outcomes in complaint management, CAPA, and NPI quality leadership. Demonstrated ability to build test capabilities, lead cross-functional investigations, and deliver measurable operational savings. Brings deep regulatory knowledge, audit readiness, and hands-on systems experience to accelerate quality and compliance programs.
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