About this Candidate
DAVRON CV: Candidate 1874566
MANUFACTURING & QUALITY ENGINEER | PROCESS VALIDATION, FDA COMPLIANCE, CONTINUOUS IMPROVEMENT
Core Expertise
- Process validation and qualification for medical and pharmaceutical manufacturing environments.
- Establishing and maintaining quality systems compliant with CFR 820 and ISO 13485.
- Generating FDA-ready documentation including Design History Files and reconciliation memorandums.
- Leading continuous improvement initiatives using Six Sigma and Lean to improve throughput.
- Supplier quality management, CAPA ownership, and nonconformity disposition.
Project Background
- Optimized throughput on a high-volume automated prescription line through pick-location redesign.
- Led expansion and decommission projects for over-the-counter product lines with cross-functional teams.
- Developed and executed IQ/OQ/PQ test plans and validation reports for new line components.
- Remediated Design History Files and supported audit readiness for regulated products.
- Implemented supplier corrective actions and conducted supplier process and quality assessments.
Key Skills
- Process Validation | IQ/OQ/PQ | Protocol Development
- Design History File (DHF) Generation | FDA Compliance Documentation
- PFMEA | Control Plans | Process Flows
- CFR 820 | ISO 13485 | Quality Management Systems
- CAPA Management | Non-Conformance Reporting | Supplier Corrective Action
- Continuous Improvement | Six Sigma | Lean Manufacturing
- Data Analysis | Time Studies | Performance Trending
Education
- B.S., Biomedical Engineering — Indiana Institute of Technology
Awards & Recognition
- Employee recognition award for outstanding contribution (2017, 2018)
- Employee excellence award (2019)
Why Interview this Candidate?
A seasoned manufacturing and quality engineer with 10+ years driving process validation, FDA compliance, and high-volume line optimization. They have led cross-functional validation and remediation projects, implemented supplier CAPAs, and delivered measurable efficiency gains through pick-location and transit-time improvements. Well-suited to lead validation and continuous-improvement efforts in regulated manufacturing environments.
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