Quality Engineer

Quality EngineerLocation: Orwell, OHDirect hire – OnsiteSalary: 85 – 95K+ Depending on experienceMust be able to work without the need for sponsorshipJob SummaryThe Quality Engineer will support the Quality Management System (QMS) and quality performance for assigned manufacturing areas, work centers, and product families. This position will focus on customer quality, complaint resolution, root cause analysis, corrective actions, non-conforming material, process improvement, and new product/process qualification.The Quality Engineer will work closely with Manufacturing, Engineering, Operations, Sales, and Quality leadership to improve customer satisfaction, reduce quality-related costs, and ensure compliance with established quality standards and procedures.Weekend or off-shift support may occasionally be required based on production or customer needs.Key ResponsibilitiesCustomer Quality & Complaint ResolutionManage and investigate customer quality complaints from initial notification through final resolution.Coordinate customer complaint activities using CRM and quality tracking systems.Lead and complete 8D investigations and corrective action reports within required customer timelines.Perform root cause analysis and develop effective containment, corrective, and preventive actions.Work cross-functionally with Engineering, Manufacturing, Sales, and Operations to resolve customer quality concerns.Monitor customer quality metrics, including complaint trends, response time, and PPM performance.Identify recurring or systemic quality issues and recommend continuous improvement initiatives.Serve as an internal voice of the customer regarding product quality and performance.Root Cause & Corrective ActionFacilitate structured problem-solving activities for internal and external quality issues.Utilize appropriate root cause analysis tools to determine the source of product and process failures.Develop and implement corrective and preventive actions to eliminate recurrence.Verify the effectiveness of corrective actions through follow-up audits, data analysis, and process monitoring.Lead or participate in cross-functional quality improvement teams.Non-Conforming Material & MRBSupport and participate in the Material Review Board (MRB) process.Evaluate and disposition non-conforming or suspect material.Coordinate containment activities to protect customers and production operations.Drive problem-solving activities for significant or recurring non-conformances.Analyze scrap, rework, first-pass yield, and other quality-related cost metrics.Recommend process improvements to reduce scrap, rework, and quality-related financial losses.Quality Management SystemSupport the maintenance and continuous improvement of the site's ISO-based Quality Management System.Develop, update, and maintain quality procedures, work instructions, control plans, inspection requirements, and supporting documentation.Conduct and participate in Internal Quality Audits and Layered Process Audits (LPAs).Audit manufacturing processes against documented procedures and quality requirements.Communicate audit findings and work with responsible teams to implement corrective actions.Support compliance with corporate, customer, regulatory, and quality system requirements.Partner with site and corporate quality leadership to ensure consistent QMS implementation.Process & Product QualityAnalyze product and process data to identify trends and improvement opportunities.Determine when process stability and capability studies are required.Perform or support process capability and statistical analysis.Recommend process changes and verify their effectiveness after implementation.Establish and maintain Process Control Plans.Provide technical support for inspection methods and measurement techniques.Utilize Measurement System Analysis (MSA) to evaluate measurement system capability.Support the development and maintenance of Failure Mode and Effects Analysis (FMEA) documentation.Apply Statistical Process Control (SPC) techniques as appropriate.New Product & Process LaunchSupport new product introductions, manufacturing process changes, and product modifications.Identify potential quality risks prior to product or process launch.Participate in FMEA, Control Plan development, capability analysis, and risk mitigation activities.Support or lead PPAP and product qualification activities.Verify that customer and internal quality requirements are satisfied prior to production release.Monitor new or changed processes following implementation to ensure corrective actions and process controls are effective.Quality Tools & MethodologiesCandidates should have experience with several of the following:Root Cause AnalysisCorrective and Preventive Action (CAPA)8D Problem SolvingFailure Mode and Effects Analysis (FMEA)Process Control PlansStatistical Process Control (SPC)Measurement System Analysis (MSA)Layered Process Audits (LPA)Process Capability AnalysisPPAP / Product QualificationMaterial Review Board (MRB)Design of Experiments (DOE)Continuous Improvement methodologiesQualificationsBachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or a related technical discipline preferred.Previous Quality Engineering experience within a manufacturing environment.Strong experience with customer complaints, root cause analysis, corrective actions, and 8D problem solving.Working knowledge of ISO-based Quality Management Systems.Experience supporting internal audits and manufacturing process audits.Experience with non-conforming material and MRB processes.Understanding of FMEA, Control Plans, SPC, MSA, PPAP, and other quality core tools.Experience analyzing manufacturing and quality data to identify trends and improvement opportunities.Working knowledge of ERP systems such as SAP or similar manufacturing ERP platforms.Strong problem-solving and analytical skills.Ability to develop clear process documentation, procedures, and quality records.Strong written and verbal communication skills.Ability to work effectively within cross-functional teams and manage complex quality issues.Comfortable communicating with production operators, supervisors, engineers, plant leadership, corporate quality teams, and customers.Preferred BackgroundQuality Engineering experience in a high-volume or technically complex manufacturing environment.Experience directly supporting customer complaint investigations and corrective action activities.Experience supporting new product launches and PPAP.Familiarity with ISO quality standards and structured continuous improvement methodologies.Hands-on experience working directly with manufacturing processes, inspection systems, and production teams. Kelly