Quality Technician - 3rd Shift

American Sterilizer Company (US)•Pagedale, MO

2d•$20 - $26•Onsite

About The Position

The Quality Technician is responsible for assisting in the administration of quality functions at a site to ensure 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.

Requirements

High School Diploma with +3 years of experience in a manufacturing/repair environment/other technical production OR Associates Degree with +1 year of experience in a manufacturing or repair environment.
Experience with math including ratios, proportions and basic algebra.
Ability to work in a fast-paced environment with strict deadlines.
Ability to read and comprehend written instructions, safety warning labels, and machine instruction manuals.
Ability to generate detailed, high-quality documentation.
Ability to work with others in analyzing and solving technical problems.
Ability to collaborate with others and works in a professional manner to support team actions.
Ability to work with minimal supervision, and have basic computer skills, including Excel and Word.
Cross train in aseptic department.
May be expected to move, carry, and lift approximately 50 pounds.

Nice To Haves

Previous experience in a regulated industry: ISO 13485 & FDA specifically.
Previous experience in aseptic gowning.
Previous experience with GDP (good documenting processes).
Experience working in chemical manufacturing.

Responsibilities

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.