Skills
Quality Assurance, FDA Regulations (21 CFR Part 820, 210, 211), ISO 13485, ISO 14971, CAPA, NCR, Risk Management, Root Cause Analysis, Validation Protocols (IQ/OQ/PQ), Supplier Audits, Design Control, Post-Market Quality, Regulatory Reporting (MedWatch 3500a), New Product Introduction (NPI), Process Improvement, Data Analysis, MS Office (Advanced Excel), HP-ALM, Minitab, Cross-Functional Collaboration, Continuous Improvement, Product Quality, Compliance, Technical Documentation, Change Control, FMEA, PFMEA, Gauge R&R, Statistical Analysis.
About
Quality Engineer with 8+ years of experience in the medical and healthcare industries, specializing in FDA regulations (21 CFR Part 820, 210, 211), ISO 13485, and ISO 14971 compliance. Expertise in Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), risk management, and validation protocols (IQ/OQ/PQ). Skilled in supplier audits, root cause analysis, and post-market quality support, including complaint investigations and regulatory reporting (MedWatch 3500a). Proficient in MS Office, HP-ALM, and Minitab for data analysis. Proven ability to drive continuous improvement, ensure product quality, and collaborate with cross-functional teams in fast-paced, matrixed environments.
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