Medical Device Quality Engineer

Job Summary

Seeking a remote contract Medical Device Quality Engineer, the candidate will lead investigations into electrical failures, conduct root cause analyses, and collaborate with cross-functional teams to implement corrective actions, ensuring product quality and regulatory compliance over a 6-12 month period.

Key responsibilities:

• Lead investigations of electrical failure modes related to medical device field returns and customer complaints
• Conduct root cause analyses using structured methodologies such as 5-Why and Fishbone
• Drive Corrective and Preventive Action (CAPA) activities for electrical and electronic product issues

Required qualifications:

• Bachelor's degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or a related field
• Experience in electrical failure investigations and root cause analysis within the medical device industry
• Strong understanding of electrical circuits and common failure mechanisms
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, FMEA, and CAPA
• Ability to interpret technical documentation and engineering data