Medical Device Quality Assurance Technician (ISO 13485/MDSAP)

STERIS • Chesterfield, MO

2d

About The Position

Step into a day where quality protects patients You grab your notebook and log into our global quality system. A production line pause pops up—within minutes, you’re on the floor confirming evidence, scoping the issue, and launching a documented investigation. By midday you’re coordinating in-process sub-assembly checks and final product acceptance tests; by afternoon you’re verifying calculations and dose ranges, confirming dosimeter placement and special instructions prior to processing, and clearing a batch for release after a thorough Device History Record (DHR) review. Before you wrap, you complete a calibration task, record environmental monitoring results, and close out your Material Review Board (MRB) notes. What you will do Support manufacturing and servicing operations by performing and documenting problem-solving investigations, including production line stoppages and associated corrective actions. Coordinate and conduct in-process and final QC product acceptance testing for sub-assemblies and finished devices. Identify and document product and process nonconformances; participate in MRB activities to disposition nonconformance reports. Review DHRs and support batch record and product/process release decisions. Enter and retrieve quality data in local and global systems to maintain complete, accurate records. Perform site calibration activities and maintain traceable records. Execute environmental monitoring and associated documentation. Verify calculations, dose ranges, dosimeter placements, and any special instructions prior to processing and as part of final product release. Carry out other quality-related duties as assigned. The standards you’ll champion Our products and processes align to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory requirements. You will help ensure day-to-day adherence in everything we build, test, document, and release. What you bring Required (one of the following): High school diploma or GED plus at least 3 years of experience in a manufacturing or repair setting or in technical production tasks; or Associate’s degree plus at least 1 year of experience in a manufacturing or repair setting or in technical production tasks. Preferred: Hands-on experience working with electrical wiring in a testing capacity. Proficiency with measuring tools. Demonstrated skill in visual inspection and hands-on product evaluation. If you thrive on meticulous documentation, structured problem-solving, and seeing safe, compliant product move to patients, this role will feel like home.

Requirements

• High school diploma or GED plus at least 3 years of experience in a manufacturing or repair setting or in technical production tasks; or Associate’s degree plus at least 1 year of experience in a manufacturing or repair setting or in technical production tasks.

Nice To Haves

• Hands-on experience working with electrical wiring in a testing capacity.
• Proficiency with measuring tools.
• Demonstrated skill in visual inspection and hands-on product evaluation.

Responsibilities

• Support manufacturing and servicing operations by performing and documenting problem-solving investigations, including production line stoppages and associated corrective actions.
• Coordinate and conduct in-process and final QC product acceptance testing for sub-assemblies and finished devices.
• Identify and document product and process nonconformances; participate in MRB activities to disposition nonconformance reports.
• Review DHRs and support batch record and product/process release decisions.
• Enter and retrieve quality data in local and global systems to maintain complete, accurate records.
• Perform site calibration activities and maintain traceable records.
• Execute environmental monitoring and associated documentation.
• Verify calculations, dose ranges, dosimeter placements, and any special instructions prior to processing and as part of final product release.
• Carry out other quality-related duties as assigned.

What This Job Offers

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