The Quality System Specialist will assist in the updating and consolidation of legacy product technical and risk management files related to IVDR. Responsibilities include:

• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards


• Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather information and data required for the completeness and accuracy of risk profiles for existing hazards, and identifying new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations.


• Supporting the migration of product risk management files into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF binders in coordination with DHF migration efforts.