About this Candidate
DAVRON CV: Candidate 1921362
MEDICAL DEVICE QUALITY ENGINEER | SUPPLIER QUALITY, AUDITS & REGULATORY COMPLIANCE
Core Expertise
- Supplier quality management including qualification, audits, SCARs, and CAPA oversight.
- Regulatory compliance to ISO 13485:2016 and 21 CFR Part 820 with audit leadership.
- Validation oversight of IQ/OQ/PQ and production test method development.
- Root cause analysis and risk management driving durable corrective actions.
- Statistical process control and data-driven performance monitoring using Minitab and Infinity QS.
Project Background
- Led supplier qualification and selection for new product lines across multiple vendors.
- Developed and validated a cross-vendor mechanical test method with R&D collaboration.
- Implemented supplier in-process data monitoring to identify trends and reduce defects.
- Standardized Device History Records, eliminating manual-entry errors.
- Improved final test methods, reducing gage R&R from 70% to 16%.
- Reduced supplier-related NCMRs by 30% year-over-year through focused corrective actions.
Key Skills
- Minitab | Infinity QS | SPC
- ETQ | Cloud PLM | Enovia | SAP
- IQ/OQ/PQ Validation | Test Method Development | DHR
- Root Cause Analysis | CAPA | SCAR | Risk Management
- ISO 13485:2016 | 21 CFR Part 820 | Internal Auditing
- Injection Molding | Stamping | Grinding | Medical assembly processes
Education
- M.S., Engineering Management — Minnesota State University
- B.S., Mechanical Engineering — Minnesota State University
Awards & Recognition
- ASQ Certified Medical Device Auditor (CMDA)
- ASQ Certified Quality Engineer (CQE)
- ISO 13485:2016 Lead Auditor
Why Interview this Candidate?
A seasoned medical device quality engineer with 10+ years driving supplier quality, validations, and audit programs. Consistent record of measurable improvements—30% reduction in supplier NCMRs, major gage R&R improvement, and elimination of DHR manual-entry errors—combined with certification as a medical device auditor. Strong collaborator across R&D, manufacturing, and suppliers ready to strengthen supplier quality and regulatory compliance.
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