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Arthrex California Inc.

Quality Specialist

Arthrex California Inc., Santa Barbara, CA, United States


Essential Duties and Responsibilities: Coordinate and lead assigned tasks supporting the complaint investigation process: Coordinate the investigation by inspecting devices, preparing devices for engineering evaluations or following through with vendor evaluations. Record detailed observations of products as received and confirm by evidence any non-conformances reported with the product. May review operating room reports, bills of lading, device history records, communications with customers and other documentation to extract relevant investigation information. Report back to customers or designated internal staff with findings in written or verbal format as requested. Manage, assemble, maintain standard closing statements and own the closing tasks. Coordinate and lead assigned tasks supporting the nonconformance (NC) process Identify and initiate nonconformances and deviations as requested by Quality Engineers or as identified in QC Inspection Assist with scoping and perform containment actions for nonconforming product, including material transactions in the ERP/MRP system and PLM System (SAP, Agile) Verify Nonconformance Record (NCR) information and determine correct Team members Communicate creation and status of nonconformances to applicable internal and external Team members Support the Disposition Planning and Evaluation tasks with Team members Perform final review and closure of NCRs. Assist in the creation and presentation of Quality Metrics. Assist QA and Engineering functions with sampling and ad hoc (non-routine) inspection/testing requests to support engineering studies, validation, and environmental and process monitoring. May support standard inspection activities. Assist with general regulatory compliance and medical device report submission activities. Record accurate and consistent information in a high volume work area. Maintain accurate and complete files by supporting archival activities such as scanning/archiving. Individual productivity is consistent maintaining throughput and tasks assigned by the QA/QC Manager. Priorities are aligned with