Medical Device Quality Control Technician (Aseptic Operations)

$20.43 - $25 per hour

STERIS - Manufacturing Facilities

Job Description

Be the quality engine for aseptic production

Strengthen safe outcomes by ensuring our processes and products meet rigorous global standards: ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. You’ll support both manufacturing and servicing activities with hands-on testing, swift investigations, and airtight documentation.

Your role

Drive line-side quality investigations; partner with operations to execute corrective actions.
Conduct in-process and final QC acceptance testing (facility-dependent).
Capture and manage nonconformances for products and processes; serve on the Material Review Board.
Review DHRs and support batch release decisions.
Maintain accurate quality records within local and global systems.
Own calibration tasks and documentation; perform environmental monitoring.
Verify calculations, dose ranges, dosimeter placements, and special instructions prior to processing and at final release.

Must-haves

Education/experience: High School Diploma + 3 years in manufacturing/repair/technical production; or Associate’s Degree + 1 year in manufacturing or repair.
Math fluency with ratios, proportions, and basic algebra.
Proven ability to meet strict deadlines, and to:
- Interpret written instructions, safety warnings, and machine manuals.
- Produce thorough, high-quality documentation.
- Troubleshoot collaboratively and professionally.
- Work independently with basic Excel and Word skills.
- Cross-train within the aseptic area.
Capability to move, carry, and lift approximately 50 lbs.

Nice-to-haves

Regulated industry background (ISO 13485, FDA).
Aseptic gowning proficiency.
Good Documentation Practices (GDP).
Chemical manufacturing experience.

Where and when you’ll work

Location: 7405 Page Ave, St. Louis, MO
Shift: 2:00 PM – 10:30 PM (2nd shift); overtime as needed
Pay: $20.43 – $25 per hour + bonus

Tools, methods, and standards

Proficiency: Hazardous Materials; Lean Manufacturing Principles; GMP; Experience in a Manufacturing Environment; Aseptic; Aseptic Gowning; ISO 9001; Oracle System Experience.
Regulatory alignment: ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR.

Physical expectations

Bending, walking, standing, sitting, typing, hand manipulation, and visual acuity.
Lift/push/pull 25–50 lbs as needed.

Growth, stability, and rewards

Market-competitive pay
Extensive PTO plus 9 additional holidays
Medical, dental, and vision benefits
Short- and long-term disability
401(k) with company match
Maternity and paternal leave
Optional add-ons/discounts (e.g., Pet Insurance)
Tuition reimbursement and continuing education
Clear pathways for advancement and a stable, long-term career

If you’re motivated by precision, pace, and purpose, this role puts your quality expertise at the center of patient safety.

Apply

Vacancy posted 2 days ago

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