Medical Device Quality Control Technician (Aseptic Operations)

Job Description

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.