Engineering - Senior Engineer, Quality Assurance Engineering - Individual Contr

What You Bring

• A bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field (required).
• 4+ years of industry experience in quality engineering.
• 2+ years supporting EU MDR programs or initiatives.
• Knowledge of change management and Quality Management System (QMS) principles.
• Strong problem-solving, analytical, and critical thinking skills, and the ability to make sound engineering decisions on your own.
• Excellent written and verbal communication skills and close attention to detail.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• The ability to manage multiple priorities in a fast-paced environment with minimal supervision.
• A collaborative, stakeholder-focused approach and the ability to build trust across teams.

Nice to Have

• Medical device industry experience.
• Familiarity with ISO 13485, EU regulations, GDP, and GMP.
• Knowledge of risk-based and statistical methods.

Additional Details

• Fully remote, with up to 10% travel.