Risk Management Specialist
Sterling Life Sciences - Atlanta, GA

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Partial Job Description
1) Manage and maintain risk management program and customer feedback program
2) Establish and maintain risk management program policies and procedures in compliance with ISO 14971
3) Manage Risk Management Program by establishing and maintaining necessary Risk Management Packages to support product lines and corporate projects
4) Work with project teams and departments to identify appropriate clinical hazards, probabilities, severities and mitigations for risk analyses
5) Ensure annual review of risk management packages are performed according to schedule
6) Evaluate labeling, process and product changes for risk management impact
7) Work with all company departments, such as Complaints, CAPA and customer feedback to track post-production risk management
8) Establish and maintain customer feedback program SOPs and reports
9) Evaluate customer feedback for impact to areas such as design input
10) Maintain knowledge of all applicable standards, regulations and procedures related to tissues and products, both internal and external

Qualifications / Skills Required
1) University Degree is required; preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply
2) Appropriate full-time work experience is mandatory. No students or fresh graduates please