Quality Assurance Specialist

4 weeks ago


Saint Paul, Minnesota, United States Experis Full time

Job Title: Quality Control Technician


Location:


Client:


Max Payrate:


Duration:


Overview:


As a Quality Assurance Technician, you will support manufacturing in the Structure Heart Division of Abbott, reporting to the Manager of Quality. Key responsibilities include:


  • Support document control, such as taking ownership of change orders and activities for coworkers.
  • Maintain Device History Record (DHR) and Lot History Record (LHR) logs, including creation of new lot numbers and subsequent updates.
  • Assist in and/or perform final review of manufacturing DHR/LHR at close of or during the manufacturing process and product release.
  • Compile and archive completed and approved DHR/LHR.
  • Compile and archive completed and approved incoming inspection records.
  • Support incoming inspection as needed, including understanding and utilizing measuring tools/fixtures, material specifications, and inspection requirements.
  • Support equipment controls and calibration/PM activities, such as coordination with calibration/PM subject matter experts and updating equipment logs.
  • Compile and archive various quality records in accordance with internal procedures and external standards/regulations.
  • Communicate with coworkers and management in the event of a nonconformance incident.
  • Support cross-functional areas as needed.


Requirements:


  • High school diploma or equivalent qualification.
  • 1+ years' experience working in manufacturing or a related field.
  • Excellent knowledge of MS Office and Excel.
  • Good math and technical skills.
  • Working knowledge of quality control standards and testing techniques.
  • Positive and cooperative communication and collaboration skills.
  • Working knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable worldwide regulator requirements.
  • Multitasking, prioritization, and meeting deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as a high level of attention to detail and accuracy.
  • Ability to maintain regular and predictable attendance.
  • Must be an effective team player with the ability to train other technicians.


Preferred:


  • 1+ years prior medical device experience.


Language: English



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