Senior Quality Assurance Engineer

Sr. Quality Assurance Engineer - Medical Devices- Full Time Permanent - 5 Days Onsite We are seeking a Sr. Quality Assurance Engineer to support product development and ensure design quality within a fast-paced, Class III medical device environment. This individual will play a critical role in risk management activities and design validation processes to support innovative cardiovascular technologies.Key **Lead and review risk management activities, including DFMEA.Evaluate and approve design documentation throughout the development lifecycle.Support design verification and validation, including test method validation.Collaborate cross-functionally with engineering and manufacturing to ensure quality integration into design and production processes.Investigate non-conformances and drive corrective/preventive actions.Participate in internal audits and ensure compliance with quality system regulations.**Bachelor's degree in engineering, life sciences, or related field.Minimum 5 years of experience in an FDA-regulated medical device environment.Solid knowledge of design control, risk management, and validation (IQ/OQ/PQ).Strong organizational and communication skills.

Created: 2025-05-31