The essential requirements of the job include**:(NOTE For Hiring Manager: Please reference the 3-5-7 Job Requirements Model)
· Bachelor’s degree in Engineering, Data Science, Statistics, Quality Engineering, or a related technical field.
· 5+ years of experience in quality engineering, quality systems, or post-market surveillance with a strong focus on data analytics and reporting.
· Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, Quality System Regulations, and medical device or IVD quality requirements.
· Experience developing dashboards and reports using Power BI and advanced data analysis tools.
· Proficiency with SQL, Excel, and statistical analysis software such as Minitab, JMP, R, or Python.
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
· Ability to travel up to 5% of the time, including occasional overnight travel.
· Ability to work in a remote office environment and use standard computer equipment.
· Must be able to comply with all applicable safety standards and procedures, including the use of required PPE when visiting laboratory or manufacturing environments.