Manufacturing Quality Systems and CAPA Engineer

Durex Manufacturing
  • Cary, IL
  • $100,000 Per Year
2 days ago

Job Description

Is This You?

  • 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.

What You’ll Bring

  • 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)

Compensation

$80,00.00 - $100,000.00 annually

Compliance

Must be authorized to work in the US without sponsorship, both now and in the future.

Numbers & Facts

LocationCary, IL

Skills

  • 8Dunmatched
  • AS 9100unmatched
  • Advanced Product Quality Planning (APQP)unmatched
  • Analysis Skillsunmatched
  • Best Practicesunmatched
  • Capability Maturity Model (CMM)unmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Customer Relationsunmatched
  • Data Analysisunmatched
  • Detail Orientedunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • Failure Reporting Analysis and Corrective Action System (FRACAS)unmatched
  • Follow Throughunmatched
  • ISO 9001unmatched
  • Leadershipunmatched
  • Machine Toolunmatched
  • Manufacturingunmatched
  • Manufacturing Systemsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Mentoringunmatched
  • Metricsunmatched
  • Metrologyunmatched
  • Microsoft Officeunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Procedure Developmentunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Improvementunmatched
  • Production Part Approval Process (PPAP)unmatched
  • Quality Assuranceunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Controlunmatched
  • Regulatory Requirementsunmatched
  • Scorecardingunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Systems Administration/Managementunmatched
  • Systems Engineeringunmatched
  • Team Lead/Managerunmatched
  • Tolerance Analysisunmatched
  • Validation Planunmatched
  • Vendor/Supplier Managementunmatched
  • Writing Skillsunmatched

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