Job Title – Quality Assurance Specialist

Location - San Diego, CA

Duration – 6+ Months Contract

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Description:

This role will primarily be responsible for remediating Risk Management Files for medical devices to ensure compliance with ISO 14971:2019. The effort will consist of development of new and/or updating existing risk management deliverables and hazard analyses which currently comply to ISO 14971:2007. The role will require collaboration with cross-functional teams to establish accurate hazards identification and measurements using established procedures and criteria.

Responsibilities:
• Facilitate appropriate collaboration and completion of risk management deliverables including, but not limited to:
o Preliminary Hazards List
o Risk Management Plan
o System Hazards Analysis
o Risk Management Report

• Review and collaborate on other risk management deliverables including, but not limited to:
o Health Hazard Analysis
o Fault Tree Analysis
o Failure Modes and Effects Analysis
o Benefit Risk Analysis

• Conduct hazards analysis using available historical, test and market data related to the product.
• Provide timely updates to the business regarding remediation effort.

Qualification/Skill Set:
• 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.