Overview
On Site
Full Time
Skills
Product Analysis
Testing
Root Cause Analysis
System Requirements
ROOT
Risk Analysis
Technical Writing
Medical Devices
Pharmaceutics
ISO 9000
Quality Management
Job Details
Roles & Responsibilities:
- Bachelor's Degree in an Engineering discipline from an accredited institution required.
- Complaint product analysis and testing per procedures and requirements.
- Root cause analysis and supports conclusions with objective evidence and sound rationale. Complaint risk analysis and complaint history reviews.
- Knows and applies Quality System requirements and any appropriate FDA and international standards.
- Must have an understanding of root cause and risk analysis as well as technical writing.
- Previous experience in the Medical Device or Pharmaceutical FDA regulated environment required.
- Product complaint investigation and handling.
- Experience with FDA/ISO quality management system regulations.
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