Principal Quality Engineer

Job Category: Business Professional Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Duration: 05 Months Contract Total Hours/week: 40.00 Client: Medical Device Company No H1B’s Roles & Responsibilities Remediating Risk Management Files for medical devices to ensure compliance with ISO 14971:2019. Development of new and/or updating existing risk management deliverables and hazard analyses which currently comply to ISO 14971:2007. Collaboration with cross-functional teams to establish accurate hazards identification and measurements using established procedures and criteria. Facilitate appropriate collaboration and completion of risk management deliverables including: Preliminary Hazards List Risk Management Plan System Hazards Analysis Risk Management Report Review and collaborate on other risk management deliverables including: Health Hazard Analysis Fault Tree Analysis Failure Modes and Effects Analysis 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. Qualifications & Experience 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). Typically requires a Bachelor’s degree and/or 5+ years of applicable experience. #J-18808-Ljbffr MillenniumSoft Inc