Quality Technician : Inspection and Testing

Duties and Responsibilities :

Work effectively with the Quality, Operations, and R&D departments to perform all work accurately, with a sense of urgency and a positive attitude. Activities include the following :

• In-Process and Final Device Inspection and Test : Support Manufacturing as the QC inspector for clean-room & packaging inspection activities. Perform and document in-process and final inspection / test of devices and sub-assemblies. Provide inspection / test assistance to R&D, Operations and Quality Engineering in support of design and process verification / validation activities.
• Receiving Inspection and Test : Perform and document receiving inspection / test of device components & raw materials in accordance with drawings / specifications. Maintain accurate & timely records of inspection activities and recording such activities in the QC Receiving Log.
• Non-Conforming Materials : Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Initiate NCRs and notify the workstream owner in a timely manner. Execute and record disposition activities in accordance with approved NCRs.
• Microbiological Monitoring : Participates in periodic microbiological and particulate testing of the cleanroom and products as required.
• Returned Goods Authorization : Perform timely inspections and maintain accurate records of all returned TriSalus products through the RGA process. Correctly dispositions returned product as defined in approved procedures.
• Quality Record maintenance : Receive, verify, scan and physically file Quality Records in an organized manner as needed.
• Shipping QC : Verify TriSalus products and associated paperwork are accurate and complete prior to shipment.
• Audit Assistance : Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar).
• GP Dynamics : Transfer released materials in the ERP software for material management as needed.
• Training Record support : Enter complete training / certification records into the eQMS as needed.
• General : Perform other quality inspection, test or administration activities as assigned.

Qualifications

Education & Certifications :

Work Experience :

Knowledge, Skills & Abilities :

Physical Requirements :