Customer Quality & Process Validation Engineer

Durex Manufacturing

  • Cary, IL
  • 1 day ago
  • $100,000 Per Year

Highlights

As our Customer Quality & Process Validation Engineer, you will be the primary bridge between manufacturing and our customers—owning product quality in production, leading validation of new and revised processes, and ensuring data-driven continuous improvement. Participation across product development: validation activity planning, SPC & data analysis, control plans, technical reports, and PFMEAs.

Numbers & Facts

LocationCary, IL

Description

The Opportunity

As our Customer Quality & Process Validation Engineer, you will be the primary bridge between manufacturing and our customers—owning product quality in production, leading validation of new and revised processes, and ensuring data-driven continuous improvement. You’ll coordinate first articles, analyze nonconformances and returns, and deploy corrective and preventive actions that raise our quality performance.

A Day in the Life

Morning stand-ups find you aligning with production and engineering on open CAPAs and complaints. Midday, you might be running a PFMEA and updating control plans for an upcoming product change while preparing for a customer scorecard review. By afternoon, you’re executing failure analysis on a returned unit, facilitating an 8D, and closing the loop with stakeholders. Throughout, you’re the go-to contact for customer quality topics and the internal leader who turns issues into sustained improvements.

What You’ll Deliver

  • Direct engagement with customers to address escapes, improve scorecard metrics, and drive product/equipment qualifications.
  • Ownership of Quality System upkeep, including CAPA, complaint handling, and internal/external audits.
  • Hands-on leadership of improvement initiatives to meet and exceed customer quality targets.
  • Participation across product development: validation activity planning, SPC & data analysis, control plans, technical reports, and PFMEAs.
  • Collaboration on print/design reviews; identification of key characteristics and controls.
  • Assurance that products comply with customer specifications and applicable regulations.
  • Facilitation of cross-functional response on quality events, ensuring clear and timely communication.
  • Introduction and validation of process, tooling, equipment, and QA methodology enhancements.
  • Root-cause verification and failure analysis for returns, with effective corrective action deployment.
  • Creation of sampling plans and data analysis frameworks to monitor performance and enable improvements.
  • Leadership of problem-solving teams to resolve issues and institutionalize best practices.
  • Project team participation providing QA oversight for new and modified manufacturing processes.
  • Internal leadership and mentorship to elevate quality thinking and execution.
  • Primary quality point-of-contact for assigned customers.
  • Use of quality tools to analyze problems and implement durable solutions, including 8D documentation.
  • Guidance on review and disposition of internal nonconformances, tracking metrics for accountability.

Qualifications

  • Bachelor’s degree in Engineering or a related technical field, or equivalent experience.
  • 5+ years supporting industrial manufacturing products.
  • Hands-on ISO 9001 Quality Management System experience and Lean implementation for continuous improvement.
  • Track record of direct customer-facing quality support.
  • Exceptional communication, organization, analytical, and interpersonal skills.
  • High attention to detail and proficiency with Microsoft Office.

Professional Proficiencies

  • Process Failure Mode and Effects Analysis (PFMEA)
  • Advanced Product Quality Planning (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

Tools & Technologies

  • 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.

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