Help STERIS deliver safe, compliant products by embedding quality into every build. If you excel at disciplined documentation, root-cause thinking, and hands-on testing, this role is for you.
Role Snapshot
Champion compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR.
Drive in-process and final product acceptance testing (as applicable to the facility).
Unblock production by investigating stoppages and implementing corrective actions.
Log product/process nonconformances and collaborate with Operations to resolve them.
Serve on the Material Review Board to evaluate and disposition nonconforming material.
Review DHRs and assist with batch record release decisions.
Record and retrieve data in local/global quality systems for full traceability.
Execute calibration activities and keep meticulous records.
Perform environmental monitoring and maintain associated documentation.
Confirm calculations, dose ranges, dosimeter placement, and special instructions ahead of processing and final release.
Schedule & Comp
Shift: 2:00pm – 10:30pm (2nd shift); overtime as needed
Pay: $20.43 – $25.00/hour + bonus
Location: 7405 Page Ave, St. Louis, MO
Minimum Qualifications
HS Diploma + 3+ years in manufacturing/repair/technical production; or Associate’s + 1+ year in manufacturing/repair.
Math skills including ratios, proportions, and basic algebra.
Comfort with fast-paced workflows, reading SOPs/manuals/labels, and meeting tight deadlines.
Strong written documentation; capable of generating accurate, detailed records.
Collaborative, professional demeanor; proven technical problem-solving with teams.
Self-starter with basic Excel and Word proficiency.
Open to cross-training in aseptic operations.
Ability to move and lift up to approximately 50 lbs.
Preferred Background
Experience in regulated environments—especially ISO 13485 and FDA.
Aseptic gowning capability.
Good Documentation Practices and exposure to chemical manufacturing.
Physical Demands
Bending, walking, standing, sitting, typing, hand manipulation, and visual acuity.
Lift/push/pull 25–50 lbs as needed.
Tools & Methods You Know
Hazardous Materials
FDA Regulations
Lean Manufacturing Principles
GMP
Oracle ERP/systems
Why STERIS
Market-competitive pay
Robust PTO plus nine additional holidays
Medical, dental, and vision benefits
Short- and long-term disability
401(k) with company match
Maternity & Paternal Leave
Optional add-ons/discounts (including Pet Insurance)