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 Primary Function of Position:
The Quality Assurance Product Release Associate is responsible for reviewing ION product line’s Device History Records (DHRs) for accuracy and completeness, certifying compliance to product specification and traceability requirements and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments.  The Product Release Associate receives guidance on workload prioritization from the team lead, but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support. Roles & Responsibilities:Reviews DHRs in SAP for compliance to product specifications and company traceability requirements, authorizing release of product for distribution to customers and New Product Introduction (NPI) launches.Recording of defects and coordination of the rework of rejected products with the responsible departments.Blocking and releasing of products and initiation of necessary corrective actions including effectiveness testing in coordination with the responsible persons.Ensures that any non-conformances or deviations are properly approved and documented in the DHR.Performs SAP transactions and ensures that released products are transacted in a timely manner.Works collaboratively with internal customers to resolve DHR issues in a timely manner.Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals.Regular communication exchange with related departments and represents the team in cross-functional meetings.Participation in the preparation of statistics and (test) instructions.Participates in projects or other activities as directed by management.Compliance with the current QMS, DOPs, SOPs, and the safety regulations.Perform other duties as assigned.  
