Job Description
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):
Risk Management:
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 ...