Quality Assurance Specialist
4 weeks ago
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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