<p>Duties and Responsibilities:</p> <p>Work effectively with the Quality, Operations, and R&D departments to perform and to document all work accurately, with a sense of urgency and a positive attitude. Activities include the following:</p> <ul> <li>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. </li><li>Product Testing: Perform inspection & testing for R&D, Operations and Quality Engineering in support of design and process verification/validation activities. Execute protocols and document results. </li><li>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. </li><li>Non-Conforming Materials: Identify, segregate and quarantine non-conforming materials resulting from inspection activities. Document issues on Nonconforming material report forms and obtain cross-functional approvals. Execute and record disposition activities in accordance with approved NCRs. </li><li>Microbiological Monitoring: Conducts periodic microbiological and particulate testing of the cleanroom and products as required. Reviews reports and confirms compliance, or initiates & documents investigation activities as needed. </li><li>Returned Goods Authorization: Performs timely inspections and maintains accurate records of all returned TriSalus products. Correctly dispositions returned product as defined in approved procedures. </li><li>Shipping QC: Verify TriSalus products and associated paperwork are accurate and complete prior to shipment. </li><li>Audit Support: Participate in internal and external QMS audits (internal, FDA, ISO registrar). </li><li>GP Dynamics: Transfer released materials in the ERP software for material management as needed. </li><li>Continuous Improvement: Participate in initiatives to improve quality and manufacturing processes. </li><li>Document and Communicate: Write reports, maintain trending data and communicate findings and recommendations to management. </li><li>General: Perform other quality inspection, test, training, audit, and other duties as assigned. </li></ul> <p>Qualifications</p> <p>Education & Certifications:</p> <ul> <li>High School diploma. Advanced education and/or ASQ certifications a plus. </li></ul> <p>Work Experience:</p> <ul> <li>2+ years of Quality Control inspection and/or manufacturing experience in a medical device manufacturing company. </li><li>Experience working with sterile disposable products in a cleanroom environment a plus. </li></ul> <p>Knowledge, Skills & Abilities:</p> <ul> <li>Able to read and interpret engineering drawings and specifications. </li><li>Able to read and follow quality procedures and detailed work instructions. </li><li>Able to review and update documentation, including procedures and protocols in Veeva Vault. </li><li>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. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy). </li><li>Able to accurately document results of testing and inspections using good documentation practices. </li><li>Able to understand and apply inspection sampling plans, such as C=0 or ANSI Z1.4. </li><li>Able to utilize basic math skills. </li><li>Able to use MS Word, Excel, PowerPoint, Outlook. </li><li>Must possess strong attention to detail. </li><li>Possess good communication skills and able to interact with peers in a professional manner. </li><li>Possess knowledge and application of US and international standards for quality management (FDA 21 CFR 820, ISO 13485). </li><li>Demonstrates excellent critical thinking skills. </li><li>Flexibility to adapt to changing priorities and requirements </li><li>Ability to adapt to and rapidly learn new processes. </li><li>Strong verbal and written communication skills and confidence in making inspection related decisions. </li><li>Participates as a member of cross functional technical teams to support process improvements, special projects and investigations as needed. </li><li>Approaches work tasks with a positive attitude and seeks feedback on performance to continually improve. </li></ul> <p>Physical Requirements:</p> <ul> <li>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. </li><li>Must be able to lift and carry up to 30 lbs. </li><li>Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards. </li></ul>