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Job Title:  Quality Technician

Req ID:  26955
Job Category:  Quality

Chesterfield, MO, US, 63005

Description: 

The Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem solving investigations and conducting in-process sub-assembly and final QC product acceptance testing.  Quality Technicians assist in identifying and documenting process and product non-conformances.  They work with operations team members to perform and document problem-solving investigations.  In addition, Quality Technicians may review device history records and execute calibration and environmental monitoring processes.

Position Summary

The Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing.  Quality Technicians assist in identifying and documenting process and product non-conformances.  They work with operations team members to perform and document problem-solving investigations.  In addition, Quality Technicians may review device history records and execute calibration and environmental monitoring processes.

Duties

  1. Conducts in-process sub-assembly and final QC acceptance testing.
  2. Assists in production line Quality investigations and associated problem-solving activities.
  3. Investigates production line stoppages to identify corrective actions.
  4. Identifies and documents product and process non-conformances.
  5. Participates on a Material Review Board to review and process nonconformance reports.
  6. Reviews DHR’s and supports batch record release.
  7. Enters and retrieves Quality data from local and global systems.
  8. Performs site calibration activities and recordkeeping.
  9. Executes environmental monitoring processes and recordkeeping.
  10. Complete other duties as assigned.

Education Degree

  • High School Diploma or GED

Required Experience

      • 1 year of work experience required

Preferred Experience

      • Knowledge and/or experience in working with surgical medical devices preferred.
      • Experience with electronics strongly preferred.

Skills

      • Knowledge of MS Office applications, including Word and Excel and ability to learn Oracle data management, enter data onto Oracle using well defined procedures.
      • Ability to compare surgical device to defined standard.
      • Ability to hold firm on findings related to surgical devices.
      • Teamwork: Collaborates with others. Works in a professional manner to support team actions.
      • Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.

 

  1. Conducts in-process sub-assembly and final QC acceptance testing.
  2. Assists in production line Quality investigations and associated problem-solving activities.
  3. Investigates production line stoppages to identify corrective actions.
  4. Identifies and documents product and process non-conformances.
  5. Participates on a Material Review Board to review and process non conformance reports.
  6. Reviews DHR’s and supports batch record release.
  7. Enters and retrieves Quality data from local and global systems.
  8. Performs site calibration activities and recordkeeping.
  9. Executes environmental monitoring processes and recordkeeping.
  10. Complete other duties as assigned.
Req ID:  26955
Job Category:  Quality

Chesterfield, MO, US, 63005


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