Quality Assurance Specialist

1 day ago


San Diego, California, United States MILLENNIUMSOFT Full time

Job Title – Quality Assurance Specialist



Location – Remote



Duration – 6+ Months Contract



Client: Medical Device Company



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



Job Summary:



MILLENNIUMSOFT is seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for remediating Risk Management Files for medical devices to ensure compliance with ISO 14971:2019.



Key Responsibilities:



  • Facilitate collaboration and completion of risk management deliverables, including Preliminary Hazards List, Risk Management Plan, System Hazards Analysis, and Risk Management Report.
  • Review and collaborate on other risk management deliverables, including Health Hazard Analysis, Fault Tree Analysis, Failure Modes and Effects Analysis, and 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 efforts.


Qualification/Skill Set:



  • Strong cross-functional collaboration skills.
  • 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.


What We Offer:



MILLENNIUMSOFT offers a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development.



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