TriSalus Life Sciences ยท 1 month ago
Quality Technician: Inspection and Testing
TriSalus Life Sciences, Westminster, CO, US
Full-time
Onsite
Entry, Mid Level
$54K/yr - $63K/yr
2+ years expTriSalus Life Sciences is seeking a Quality Technician to join their team in Westminster, CO. The role involves performing inspections and tests on medical devices, ensuring compliance with quality standards and assisting various departments to maintain quality assurance throughout the manufacturing process.
Biotechnology
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
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
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
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
Participates in periodic microbiological and particulate testing of the cleanroom and products as required
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
Receive, verify, scan and physically file Quality Records in an organized manner as needed
Verify TriSalus products and associated paperwork are accurate and complete prior to shipment
Help retrieve, review, organize and re-file documentation during all TriSalus site audit activities (internal, FDA, ISO registrar)
Transfer released materials in the ERP software for material management as needed
Enter complete training/certification records into the eQMS as needed
Perform other quality inspection, test or administration activities as assigned
Qualification
Required
High School diploma
2+ years of Quality Control / Inspection experience in a medical device or similar technical product manufacturing company
Able to read and interpret engineering drawings, specifications and detailed technical documents
Able to read and follow quality procedures and detailed work instructions (QLPs/OPs)
Able to perform component and product inspection/testing using tools such as microscopes, calipers, micrometers, pin gauges, depth gauges, pull force test systems and vision measuring systems
Able to accurately document results of inspections using good documentation practices
Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4
Able to utilize basic math skills
Able to use MS Word and MS Excel
Must possess strong attention to detail
Possess good communication skills and able to interact with peers in a professional manner
Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485)
Demonstrates excellent critical thinking skills
Ability to adapt to and rapidly learn new processes
Strong verbal and written communication skills and confidence in making inspection related decisions
Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed
Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve
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
Preferred
Advanced education or certifications a plus
Experience working with sterile disposable products in a cleanroom environment a plus
Company
TriSalus Life Sciences
TriSalus Life Sciences is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sean Murphy
Chief Financial Officer
Jennifer Stevens, JD
Chief Regulatory & Quality Officer
Recent News
2025-08-29
Business Wire
2025-08-13
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