Senior Risk Management Engineer

Job Summary

Leading global risk management initiatives, the full-time Senior Risk Management Engineer will create and enhance risk controls for medical devices, cosmetics, and OTC drugs while collaborating with various departments in a remote work environment.

Key responsibilities

• Create and align global risk management processes to ensure consistent risk analysis
• Evaluate risks and approve processes such as Change Controls and Failure Mode Effect Analysis (FMEA)
• Communicate risks to senior management and build relationships with quality and business partners

Required qualifications

• Bachelor of Science Degree in Biology, Chemistry, Engineering, or a Statistics-based degree
• At least 4 years of QA/QE experience in a cGMP Device environment
• At least 2 years of direct risk management experience related to FDA regulated products
• Experience creating quality sub-systems and leading complex projects
• Ability to manage multiple projects simultaneously