Quality Technician Medical Device

STERIS • Chesterfield, MO

2d

About The Position

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, authorize release of finished product/processes and execute calibration and environmental monitoring processes. Assists in production line Quality investigations and associated problem-solving activities. May coordinate and conduct in-process and final QC product acceptance testing, depending on facility. Investigates production line stoppages to identify corrective actions. Identifies and documents product and process non-conformances. Participates on a Material Review Board to review and process non conformance reports. Reviews DHR’s and supports batch record release. Enters and retrieves Quality data from local and global systems. Performs site calibration activities and recordkeeping. Executes environmental monitoring processes and recordkeeping. Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release. Complete other duties as assigned.

Requirements

• High school diploma or GED with a minimum of three (3) years experience in a manufacturing or repair environment or experience with technical production tasks.
• Associates Degree with a minimum of one (1) year of experience in a manufacturing or repair environment or experience with technical production tasks.

Nice To Haves

• Experience working with electrical wiring in a testing capcity.
• Experience using measuring tools.
• Ability to do hands on inspections using strong visual acuity.

Responsibilities

• Assists 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.
• 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.
• Assists in identifying and documenting process and product non-conformances.
• Works with operations team members to perform and document problem-solving investigations.
• Reviews device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.
• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Participates on a Material Review Board to review and process non conformance reports.
• Reviews DHR’s and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.
• Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
• Complete other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED