Sr Quality Technician

Forj Medical•Vadnais Heights, MN

About The Position

The Senior Quality Technician supports new product implementation and qualification activities by developing, validating, and executing inspection and measurement programs for Vision Systems based on engineering drawings, specifications, and part prints. The role plans, performs, and documents qualification activities, including First Article Inspections (FAI), Operational Qualifications (OQ), Performance Qualifications (PQ), Gage Repeatability and Reproducibility (GR&R) studies, and capability studies, to ensure compliance with customer, regulatory, and internal quality requirements. The Senior Quality Technician maintains measurement programs, inspection methods, and work instructions, and collaborates with Quality, Development, and Operations to support product launches, process validations, issue resolution, and continuous improvement initiatives.

Requirements

  • Minimum eight years of equivalent experience in the medical device or a similar industry, or ten years of experience in a related field.
  • Experience with hand-held measurement equipment.
  • Ability to develop, validate, and execute inspection programs for vision and probing measurement systems.
  • Proficiency in interpreting engineering drawings, specifications, dimensional tolerances, and GD&T.
  • Working knowledge of measurement system analysis techniques, including GR&R, capability studies, and validation methodologies.
  • Working knowledge of manufacturing, statistical, spreadsheet, and word processing software.
  • Ability to work independently and collaboratively in cross-functional teams supporting Quality, Development, and Operations.
  • Strong organizational and communication skills, including the ability to prioritize multiple projects and deadlines.
  • Accuracy and thoroughness, application of continuous improvement techniques, and attention to the quality of one's own work.
  • High attention to detail and a sincere work ethic for adhering to standards, policies, and procedures.

Nice To Haves

  • Vocational or technical two-year degree.
  • ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT) certification.
  • Experience with SmartScope and Keyence systems.

Responsibilities

  • Interpret part prints and specifications to develop, validate, and revise inspection programs for Vision Systems.
  • Design and validate holding fixtures and perform Measurement System Analysis, including GR&R studies.
  • Develop and maintain inspection work instructions and workmanship standards, and train operators on inspection requirements and QMS practices.
  • Support New Product Introduction (NPI) through inspection program development, qualification activities, and measurement data collection for product launches and process validations.
  • Perform measurement activities, including First Article Inspection Reports and DOE/OQ/PQ measurements to qualify new tools, processes, and equipment.
  • Identify part nonconformances and measurement outliers, then coordinate with Quality Engineers, Manufacturing Engineers, and Supervisors to resolve issues.
  • Maintain measurement equipment calibrations, including updating Vision Systems software, calibrating hand tools, submitting Purchase Order Requests with Supply Chain, and coordinating vendor appointments for updates, calibrations, preventive maintenance, and repairs.
  • Maintain and optimize qualified inspection programs to improve measurement accuracy and efficiency while adhering to Quality Management System requirements.
  • Provide production inspection support as needed.
  • Perform other duties as assigned.

Benefits

  • Comprehensive benefits program.
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