Manufacturing Quality Systems and CAPA Engineer

Durex Manufacturing
Trout Valley, IL, United States
1 day ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Compensation
$100,000
Working hours
Regular working hours

Tech stack

Data Analysis Systems Engineering Failure Mode Effects Analysis Microsoft Office Statistical Process Control (SPC)

Job description

  • Do you enjoy being the first call when a customer raises a product quality concern-and the last word on how it gets solved?
  • Are you energized by running CAPAs, closing audit actions, and strengthening ISO 9001 processes?
  • Can you translate SPC data, PFMEAs, and control plans into real, measurable improvements on the floor?

What You’ll Own

  • Customer-facing quality: tackle escapes, uplift scorecard performance, and coordinate product/equipment qualifications.
  • Quality System health: manage CAPA, complaints, and audit activities to keep the system robust.
  • Continuous improvement leadership to meet customer expectations and internal targets.
  • Active role in development activities: validation planning, SPC & data analysis, control plans, technical reporting, PFMEA contributions.
  • Design/print reviews: highlight significant characteristics and define controls.
  • Compliance ownership: ensure products conform to customer and regulatory requirements.
  • Internal response leadership: organize the team for fast, clear action on quality events.
  • Process optimization: introduce and validate improved procedures, QA methods, tooling, and equipment.
  • Returned product analysis: verify issues, perform failure analysis, and implement corrective actions.
  • Sampling strategy: devise QA sampling and associated analytics to drive improvements.
  • Problem-solving facilitation: lead teams that fix issues and prevent recurrence.
  • Project participation: deliver QA oversight for new and updated manufacturing processes.
  • Quality advocacy: mentor peers and champion best practices.
  • Primary liaison: serve as the designated quality contact for assigned customers.
  • Tool mastery: apply structured problem-solving and document Corrective-Preventive Actions using the 8D approach.
  • Nonconformance control: lead review/disposition with clear metrics and follow-through.

Requirements

Manufacturing Systems, Systems Engineering, Corrective and Preventative Action (CAPA) Systems, ISO 9001, Customer Relations, Scorecarding, Corrective and Preventative Action (CAPA) Systems, Systems Administration/Management, Continuous Improvement, Leadership, * Bachelor’s in Engineering (or similar technical discipline) or equivalent experience.

  • 5+ years in industrial manufacturing support roles.
  • Experience implementing and improving ISO 9001 and Lean practices.
  • History of direct customer engagement on quality matters.
  • Strong written/verbal communication, organization, and problem-solving skills.
  • Detail orientation and proficiency in Microsoft Office.

Your Toolkit

  • PFMEA
  • APQP
  • Supplier Management
  • Manufacturing Instruction (MI)
  • Standard Operating Procedures (SOPs)
  • AS9100 Quality Systems
  • Quality Control Experience
  • Tolerance Analysis
  • Precision Measurement & Hand Metrology
  • Advanced Inspection & Gauge Measurement
  • Quality Control Data Analysis
  • PPAP Process Experience

Tech in Our Shop

  • ERP Software
  • Coordinate Measuring Machine (CMM), Must be authorized to work in the US without sponsorship, both now and in the future.

Benefits & conditions

$80,00.00 - $100,000.00 annually

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