Medical Device Quality Control Technician (Aseptic Operations)

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.