Quality Systems Technician — ISO/FDA Compliance

Quality Systems Technician — ISO/FDA Compliance STERIS - Operations St. Louis, MO Job Details $20 - $25 an hour 11 hours ago Benefits Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Parental leave Vision insurance 401(k) matching Opportunities for advancement Pet insurance Qualifications Computer operation Word processing Algebra Manufacturing company experience Full 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