Quality Technician: Inspection and Testing

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.

High School diploma. Advanced education or certifications a plus.

2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company.

Experience working with sterile disposable products in a cleanroom environment a plus.

Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

Must be able to lift and carry up to 30 lbs.

Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards.