About The Position

Working under minimal supervision, the IQA Technician II performs inbound material inspections and tests that evaluate the precision and accuracy of products and services. Assures the optimum control of quality so that all products and services conform to existing requirements, standard operating procedures, and government regulations and adheres to all Good Manufacturing Practices (GMP). Failure to adequately perform tasks can result in noncompliance with governmental regulations typically isolated to individual supplier lots, all future lots for automated testing and poor design decisions based on data provided to engineers which could impact an entire instrument platform.

Requirements

  • High school diploma or GED
  • 3 + years of experience in increasingly difficult inspection involving the application and working knowledge of sophisticated measuring techniques
  • Experience programming CMM quality inspections
  • Solid understanding of GD&T with respect to CMM applications
  • IPC-610 certified
  • Proficient in the use of computers and computer database software (Microsoft office) for maintenance of record and logs and basic analysis of data (e.g., Excel spreadsheets)

Nice To Haves

  • Experience with ZEISS Calypso software
  • Associate degree or technical diploma
  • Advanced CMM certification
  • Experience in FDA-regulated manufacturing environments
  • Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing
  • Training in blueprint reading and experience with inspection sampling techniques
  • Knowledge of GMP and ISO 13485 requirements
  • ASQ certified Mechanical Inspector (CMI), Certified Quality Technician (CQT) or Certified Calibration Technician (CTT) highly desirable
  • Experience in increasingly difficult inspection involving the application and working knowledge of sophisticated measuring techniques
  • Understanding of material traceability and non-conforming material identification and segregation techniques.
  • Understanding of and ability to appropriately apply sampling techniques
  • Ability to train and assist less experienced inspectors

Responsibilities

  • Supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirement for receiving and inspection.
  • Performs all job duties in full accordance with the Abbott Global and Technical standards and complies with Abbott Quality System (QS) requirements.
  • Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.
  • Completes tier 1, tier 2 and tier 3 inspections to test inbound material that will be used to assemble complex medical devices.
  • Performs inspection on printed material (e.g. Primary and Secondary labeling; manuals; print inserts; CD’s; etc.).
  • Performs first article inspections
  • Set up and run CMM programs.
  • Work from process sheets and instructions from supervisor.
  • Writes simple to complex computerized measuring machine (CMM) programs for all products and submit results to engineering and manufacturing.
  • Ensures CMM’s are running at peak performance and that all required maintenance is performed on schedule.
  • Performs technical metrology lab functions such as complete dimensional layouts of complex components and assemblies with minimal guidance.
  • Programs automated testers utilizing advanced programming skills as well as validates programs used by the automated equipment.
  • Acts as subject matter expert (SME) for automated testing.
  • Interprets engineering drawings and writes the inspection method for parts for automated testing.
  • Works collaboratively with engineers to resolve drawing issues and provides feedback to R&D, Quality Assurance, Production, Engineering and Suppliers as required.
  • Uses engineering knowledge to define requirements, design, build, integrate and test designs at the component level
  • Recognizes opportunities or issues within own technical area, models options and implements process improvements that fosters a culture of continuous improvement
  • Determines and may assist in developing methods and procedures to control or modify the incoming quality inspection process.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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