Regulatory Job CT NM QA Risk Management Job

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CT NM QA Risk Management Job OH Open (J#45240)

Title: CT NM QA Risk Management Job
Company: Philips

Your Responsibilities

* Establish processes and procedures for managing medical device risk through the product life cycle; including, but not limited to Fault Tree Analysis, Failure Mode Effects Analysis, Risk Assessment, Health Hazard Evaluation, Overall Residual Risk Evaluation, and Risk Management File documentation. * Integrate risk management procedures throughout the CT/NM to ensure well-defined, consistent, documented, risk-based action thresholds and decision-making in design-related activities, production and distribution controls, service activities, complaint handling, adverse event analysis, corrective and preventive action, and management controls. * Develop and deliver training on risk management procedures, processes and techniques to cross-functional employee groups. * Mentor and support product development teams in hazard identification, risk/benefit-based mitigation and verification through application of documented design control and risk management processes. Support Regulatory Affairs team members in development of required Risk Management Plans and Risk Management Files. * Collaborate with cross-functional groups in the documented evaluation, investigation, and action planning of product, manufacturing, and service-related issues with respect to potential health risks to customers and their patients. This includes, but is not limited to complaint and adverse event analysis, nonconformance evaluation, failure investigation, risk assessment update, health hazard evaluation, corrective and preventive action. * Other engineering, manufacturing, quality, reliability, regulatory, and service support tasks as required
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