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Quality Control Inspector

4 months ago

Westminster, United States TriSalus Life Sciences Full time
Job title: Quality Control Inspector

Job Document #: JOB-00## R01

Department: Quality

Duties and Responsibilities:

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:

  • 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.
  • Equipment PM/Calibration: Participates in equipment calibration and preventive maintenance activities as required.
  • Microbiological Monitoring: Participates in periodic microbiological and particulate testing of the cleanroom and products as required.
  • Returned Goods Authorization: Performs timely inspections and maintains accurate records of all returned TriSalus products. 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:
  • High School diploma. Advanced education or certifications a plus.
Work Experience:
  • 2+ years of Quality Control / Inspection experience in a medical device manufacturing company.
  • Experience working with sterile disposable products in a cleanroom environment a plus.
Knowledge, Skills & Abilities:
  • Able to read and interpret engineering drawings and specifications.
  • 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. (Sufficient knowledge to select and use the correct measurement tool for the required inspection accuracy.
  • 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 confident 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.
Physical Requirements:
  • 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.