Customer Quality & Process Validation Engineer

Durex Manufacturing; Cary (IL); On-site; USD 80,000 - 100,000; Full time

Job summary

Durex Manufacturing in Cary, IL is seeking a Customer Quality & Process Validation Engineer to bridge manufacturing and customers, owning product quality in production and leading validation of new and revised processes. You will manage CAPAs, PFMEAs, control plans, and customer scorecards while driving data-driven improvements.

You will coordinate first articles, perform failure analyses, and lead 8D investigations with cross-functional teams, ensuring regulatory compliance and durable

Qualifications

• Bachelor’s degree in Engineering or related field or equivalent experience.
• 5+ years in supporting industrial manufacturing products.
• Hands-on ISO 9001 quality management experience with Lean.
• Direct customer-facing quality support experience.
• Strong communication, organization, and analytical skills.

Responsibilities

• Direct engagement with customers to address escapes and improve scorecard metrics.
• Own Quality System upkeep: CAPA, complaints, audits.
• Lead improvement initiatives to meet customer quality targets.
• Participate in product development: validation planning, PFMEA, control plans.
• Lead 8D problem-solving and cross-functional follow-up.

Skills

Customer-facing quality

Quality data analysis

Problem solving

Communication skills

Analytical thinking

Education

Bachelor’s degree in Engineering

Tools

ERP Software

CMM

MS Excel

Job description

The OpportunityAs 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 LifeMorning 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 DeliverDirect 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.QualificationsBachelor’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 ProficienciesProcess Failure Mode and Effects Analysis (PFMEA)Advanced Product Quality Planning (APQP)Supplier ManagementManufacturing Instruction (MI)Standard Operating Procedures (SOPs)AS9100 Quality SystemsQuality Control ExperienceTolerance AnalysisPrecision Measurement & Hand MetrologyAdvanced Inspection & Gauge MeasurementQuality Control Data AnalysisPPAP Process ExperienceTools & TechnologiesERP SoftwareCoordinate Measuring Machine (CMM)Compensation$80,00.00 - $100,000.00 annuallyComplianceMust be authorized to work in the US without sponsorship, both now and in the future.