REMEDIATION PROJECTS

(November 2013 – July 2015)

Audit Finding Remediation

Multi-billion dollar Medical Device and Pharmaceutical Company as Quality Engineer – Manage resources and timelines for combination products’ Design History File (DHF) and Risk Management File (RMF) Remediation compliant to 21CFR Part 4 – Combination Products.

­Project Lead of Quality Engineers (5), to perform DHF gap assessments, create design history files and risk management files for legacy combination products. (November 2013 – July 2015)

Manage Resources and Timelines

• Project Task identification and management
• Project Task mapping, planning, and timeline management
• Project Task tracking and resource optimization
• Weekly meetings communicating status to all organizational levels

Author/Mentor

• Remediation Protocol to standardize remediation activities across all product lines
• Review/evaluate criticality analyses, risk analyses , preliminary hazard analyses
• Research, acquire, create, approve, and release DHF support documentation
  • Design Input and Output Requirements
  • Traceability Matrices
  • Verification and Validation protocols and reports
  • Risk Management Reports

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