Quality Technician

STERIS Instrument Management Services, Inc.•Cooper City, FL

11d

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 helping perform and document problem-solving investigations and conducting 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. Depending on the facility, the role may include reviewing device history records, supporting batch record release, authorizing finished product or process release, and carrying out calibration and environmental monitoring processes. The listed schedules are Monday through Friday, either 9:00 a.m.–5:30 p.m. or 9:30 a.m.–6:00 p.m. The work is in climate-controlled facilities, and tools are provided. The position pays $21.50 per hour and is eligible for bonus participation.

Requirements

High school diploma or equivalent and at least three years of experience in a manufacturing or repair environment or other technical production tasks; alternatively, an Associate Degree and at least one year of such experience.
Mathematical skills including ratios, proportions, and basic algebra.

Responsibilities

Assist with production-line quality investigations and related problem-solving activities.
Depending on the facility, coordinate and conduct in-process and final QC product acceptance testing.
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 from 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.