Quality Systems Technician -- ISO/FDA Compliance

Job Description

Job Description Role Overview

Picture the start of your third shift in St. Louis. The line is humming, and you’re the person safeguarding quality in a highly regulated environment. As a Quality Systems Technician, you’ll help administer site-level quality activities aligned to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. You’ll partner with operations to investigate issues, document findings, and keep production moving with confidence.

Location, Schedule, and Pay

• Location: 7405 Page Ave, St. Louis, MO
• Shift: 10:00pm – 6:30am (3rd shift) + overtime as needed
• Pay: $20–$25/hr + quarterly bonus & overtime as needed

What a Night on the Job Looks Like

• Partner with production to conduct quality investigations and drive problem-solving to resolution.
• Perform and document in-process sub-assembly checks and final QC product acceptance testing.
• Respond to production line stoppages, identify root causes, and recommend corrective actions.
• Capture and manage product and process non-conformances; participate on the Material Review Board.
• Review device history records (DHRs) and support batch record release; authorize finished product/process release as applicable.
• Enter and retrieve quality data across local and global systems with precision.
• Execute and document site calibration activities.
• Carry out environmental monitoring and maintain associated records.
• Verify calculations, dose ranges, dosimeter placements, and special instructions prior to processing and during final product release.

What You Bring Required

• High School Diploma and 3+ years in a manufacturing/repair or other technical production setting; or Associate’s degree and 1+ year in a manufacturing or repair environment.
• Comfort with math (ratios, proportions, basic algebra).
• Ability to thrive under tight deadlines and in a fast-paced setting.
• Read and interpret written instructions, safety labels, and equipment manuals.
• Create clear, detailed, high-quality documentation.
• Collaborate to analyze and solve technical problems; maintain a professional, team-first approach.
• Work with minimal supervision and use basic computer tools (Excel, Word).
• Willingness to cross-train in the aseptic department.
• Ability to move, carry, and lift approximately 50 pounds.

Preferred

• Background in regulated industries, particularly ISO 13485 and FDA environments.
• Experience with aseptic gowning.
• Strong GDP (Good Documentation Practices).
• Experience in chemical manufacturing.

Other Role Demands

• Regular bending, walking, standing, sitting, typing, hand use, and visual acuity.
• Capability to lift, push, and pull 25–50 lbs as needed.

Tools & Technologies

• Calipers and Micrometers

Core Proficiencies

• ISO 13485
• FDA Regulations
• ISO 9001 Certification Experience
• Good Manufacturing Practices (GMP)

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive Pay
• Extensive Paid Time Off and (9) added holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term disability coverage
• 401(k) with company match
• Maternity & Paternal Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued educations programs
• Excellent opportunities for advancement and stable long-term career