Quality Engineer

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

Job summary

Durex Manufacturing seeks a Quality Engineer to lead quality assurance and direct customer coordination for manufacturing processes. You will drive CAPA, audits, data analysis, and corrective actions to support validation and PFMEA activities.

You will collaborate with cross-functional teams to ensure ISO 9001 compliance, apply Lean principles, and provide robust documentation and problem-solving leadership for continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years' experience in supporting industrial manufacturing products.
• Experience with ISO 9001 quality management systems and Lean manufacturing.
• Direct customer support for organizational quality is required.
• Strong verbal and written communication and problem-solving skills.

Responsibilities

• Provide quality engineering support with customers to address product quality escapes and CAPA actions.
• Lead CAPA, complaints, and internal audits.
• Support product development processes including validation, SPC, and PFMEA.
• Participate in print and design reviews and identify significant characteristics.
• Ensure products meet regulatory requirements and customer expectations.
• Lead QA oversight for new or revised manufacturing processes.
• Document corrective actions using 8D format.

Skills

Quality engineering

Customer coordination

Problem solving

Communication

Attention to detail

Education

Bachelor's degree in Engineering

Tools

MS Office

ERP software

CMM

Job description

The Role:As the Quality Engineer (QE), you will provide quality engineering and direct customer coordination and leadership for production quality and validation of manufacturing processes. Provides recommendation and coordinates improvement activities within organization and serves as the central contact point for resolving quality related issues for customers. Ensures process improvements, first articles, failure analysis on returned product, non-conforming material, quality data analysis, and applying effective corrective actions for continuous improvement results.Your Responsibilities:Activities Provides quality engineering support directly with customers to address product quality escapes, score-card improvement actions, product/equipment qualification actions.Lead Quality System maintenance activities, such as CAPA, Complaints, and audits.Leads quality improvement actions internally to achieve customer targets and expectations.Participates within the product development engineering processes, including validation activities, SPC & data analysis, control plans, report writing, and PFMEA’s as needed.Participates in print and design reviews. Identify significant characteristics and develops appropriate controls.Ensures that the products meet customer and defined regulatory requirements.Leads internal support teams on customer issues and communication as necessary on quality related events.Introduce and validate process improvements on assigned projects including procedures, QA methodologies, tooling, and equipment.Verification and Failure Analysis of returned product, with required corrective action.Devises and implements QA sampling procedures to ensure product quality, with associated quality data for analysis and improvement actions.Lead problem solving teams to address identified issues and develop improvement actions.Serve on project teams to provide QA oversight for new and revised manufacturing processes.Provide internal leadership for quality improvement actionsLead quality contact for assigned customersUtilization of quality tools for problem-solvingDocumenting Corrective-Preventative Actions within 8D formatLead review and disposition of internal non-conformances with metricsOur Requirements:Bachelor’s Degree in Engineering or related technical field or equivalent experience5+ years’ experience in supporting industrial manufacturing productsProven experience with ISO 9001 quality management systems and Lean Manufacturing principles, including implementation and continuous improvement practicesDemonstrated experience in providing direct customer support for organizational qualityStrong verbal, written communication, organization, problem-solving and interpersonal skillsMust be detailed orientedMust be proficient in Microsoft OfficeMust be authorized to work in the US without sponsorship, both now and in the future.Pay Rate: $80,00.00 - $100,000.00 annuallyYou should be proficient in:Process 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 ExperienceMachines & technologies you'll use:ERP SoftwareCoordinate Measuring Machine (CMM)