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Medical Device Quality Engineer

workfromhome • Posted 5 days ago
Remote Contract Management Occupations

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

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