Quality Technician - Weekend Shift

STERIS•Franklin Park, IL

About The Position

The Quality Technician assists with administration of site quality functions to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. The role supports manufacturing and servicing operations by conducting and documenting problem-solving investigations and in-process sub-assembly and final quality-control product acceptance testing. Quality Technicians identify and document process and product non-conformances and work with operations team members on investigations. Duties may also include reviewing device history records, supporting batch record release, authorizing release of finished products or processes, and performing calibration and environmental monitoring activities. The position is scheduled Friday through Sunday, 5:00 a.m. to 5:30 p.m. Pay is $21.50 per hour plus a $3.25-per-hour shift differential, and the role is eligible for bonus participation. The position is open until filled.

Requirements

With a high school diploma or equivalent, at least three years of experience in a manufacturing or repair environment or other technical production tasks.
With an associate degree, at least one year of experience in a manufacturing or repair environment or other technical production tasks.
Mathematical skills, including ratios, proportions, and basic algebra.

Responsibilities

Assist with production-line quality investigations and related problem-solving activities.
Coordinate and conduct in-process and final quality-control product acceptance testing, depending on the facility.
Investigate production-line stoppages to identify corrective actions.
Identify and document product and process non-conformances.
Participate on a Material Review Board to review and process non-conformance reports.
Review device history records and support batch record release.
Enter and retrieve quality data in local and global systems.
Perform site calibration activities and maintain associated records.
Execute environmental monitoring processes and maintain associated records.
Verify calculations, dose ranges, dosimeter placements, and special instructions before processing and as part of final product release.
Complete other duties as assigned.