Job Description:

We are seeking a skilled Risk & Health Hazard Evaluation (HHE) Specialist to support CAPA and post-market activities for ultrasound systems. This role is critical in ensuring patient safety, regulatory compliance, and effective risk management by evaluating field issues, complaints, and product non-conformances.

Responsibilities:

Health Hazard Evaluation (HHE):

• Perform HHE assessments for complaints, field issues, and non-conformances.


• Evaluate patient/user risk and determine severity and likelihood.


• Recommend actions such as Field Safety Corrective Actions (FSCA), recalls, or advisories.


• Support regulatory reporting decisions (FDA, EU MDR)

Risk Management:

• Conduct and update risk assessments per ISO 14971.


• Maintain and ...