Quality Assurance Specialist

Responsibilities

• Facilitate appropriate collaboration and completion of risk management deliverables including, but not limited to:
• Preliminary Hazards List
• Risk Management Plan
• System Hazards Analysis
• Risk Management Report
• Review and collaborate on other risk management deliverables including, but not limited to:
• Health Hazard Analysis
• Fault Tree Analysis
• Failure Modes and Effects Analysis
• Benefit Risk Analysis
• Carry out hazards analysis using available historical, test and market data related to the product.
• Provide timely updates to the business regarding remediation effort.

Qualifications

• Strong cross-functional collaboration skills needed.
• ISO 13485 and ISO 14971 experience a plus.
• Risk management experience (preferred).
• Experience in medical device and/or regulated industry (preferred).
• Technical experience with Pyxis or automated dispensing cabinets (preferred).
• Bachelor’s degree and/or 5+ years of applicable experience.