{"schemaVersion":"jobsearcher.job.v1","id":"b7eb6c9f2bfd205fe3f0e6b2","url":"https://jobsearcher.com/jobs/b7eb6c9f2bfd205fe3f0e6b2","canonicalUrl":"https://jobsearcher.com/jobs/b7eb6c9f2bfd205fe3f0e6b2","title":"Quality Engineer, Sr.","description":"About the RoleMedline is seeking a Senior Quality Engineer to independently support quality engineering activities with minimal supervision, including process control, validation, testing, inspection, supplier quality, and regulatory documentation. This role will lead quality improvement initiatives, evaluate production processes, analyze sources of variation, and develop solutions that improve product quality and reduce defects and failures.The Senior Quality Engineer will also provide Quality expertise across Product Development, Design Control, Risk Management, supplier management, and regulatory activities. The role requires strong analytical and problem-solving skills, the ability to manage multiple projects, and experience working cross-functionally in a regulated quality environment.Key ResponsibilitiesDevelop and implement methods and procedures for process control, process validation, process improvement, testing, and inspection.Evaluate production processes and recommend improvements to maintain product quality and functionality.Design complex experiments to identify sources of variation affecting products and processes.Apply Statistical Process Control (SPC) methods to analyze data and evaluate processes and process changes.Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.Generate and analyze reports and defective products to identify trends and lead corrective actions.Apply probability and statistical quality control concepts to support quality decisions.Collaborate with supplier representatives to resolve quality problems and ensure effective corrective actions.Lead and support supplier corrective actions, including CAPA and SCAR activities.Lead supplier qualification activities and contribute to supplier quality improvement programs.Provide Quality expertise for Product Development and Design Control activities.Support Risk Management and CE Technical File activities.Generate and maintain Device Master Records (DMRs), product specifications, design control files, and CE Technical Files.Work with Regulatory teams and suppliers on 510(k) submissions, letters to file, and related documentation as required.Coordinate product testing with internal and external laboratories.Ensure compliance with applicable domestic and international regulations for assigned products and processes.Perform quality reviews of design documentation, vendor quality documents, and company quality records.Lead investigations of product and process non-conformances and out-of-specification results.Develop and implement effective corrective and preventive actions (CAPA).Train and coach team members and Medline employees on applicable processes and best practices as needed.Act as the Quality lead in the absence of Quality Management.Required QualificationsBachelor's degree in Engineering, Science, Mathematics, or another related technical field.4+ years of experience in Quality or Engineering.Experience applying government and industry quality assurance codes and standards, including applicable examples such as 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.Ability to work independently, accomplish objectives with limited supervision, and determine when escalation is necessary.Strong time management skills with the ability to prioritize, organize, and track multiple projects and deadlines.Demonstrated problem-solving ability using mathematical or systematic approaches.Experience leading a team to accomplish cross-functional goals.Experience with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.Advanced Microsoft Excel skills, including pivot tables, pivot reporting, conditional formatting, tables, formulas, and charting.Ability to travel up to 15%.Preferred Qualifications5+ years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.Knowledge of advanced Six Sigma and Lean concepts.Skills & CompetenciesQuality EngineeringQuality AssuranceProcess ControlProcess ValidationProcess ImprovementProduct TestingInspectionStatistical Process Control (SPC)Statistical Quality ControlExperimental DesignData AnalysisRoot Cause AnalysisCorrective and Preventive Action (CAPA)Supplier Corrective Action Request (SCAR)Supplier Quality ManagementSupplier QualificationProduct DevelopmentDesign ControlRisk ManagementRegulatory ComplianceMedical Device QualityDevice Master Records (DMR)CE Technical Files510(k) SubmissionsNon-Conformance InvestigationOut-of-Specification InvestigationQuality DocumentationMicrosoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft OutlookCross-Functional LeadershipTeam LeadershipTraining and CoachingProblem-solvingTime ManagementProject ManagementEducation & ExperienceEducation:Bachelor's degree in Engineering, Science, Mathematics, or another related technical field.Experience:4+ years of experience in Quality or Engineering.5+ years of industry experience in Medical Devices, Drugs, or directly related fields is preferred.Experience with applicable government and industry quality assurance standards is required.Work Arrangement & ScheduleLocation: Chicago, Illinois, United StatesWork Arrangement: OnsiteEmployment Type: Not specified in the original job descriptionWeekly Hours: Not specifiedTravel: Up to 15%Weekend Requirements: Not specifiedCompensation & BenefitsAnticipated Salary Range: $101,000–$152,000 per yearBonus and/or incentive eligible.Health insuranceLife insuranceDisability benefits401(k) contributionsPaid time offContinuing education and trainingEmployee Resource GroupsEmployee Service Corp.Additional total rewards opportunitiesThe actual salary may vary based on location, education, experience, skills, and abilities.Compliance / Additional InformationMedline Industries, LP and its subsidiaries are Equal Opportunity Employers. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.This position involves quality activities within regulated product and manufacturing environments and requires compliance with applicable domestic and international regulations and quality standards.","company":"Torentify","rawCompany":"torentify","city":"Chicago","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-08-27T09:55:40.837Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer, Sr.","description":"About the RoleMedline is seeking a Senior Quality Engineer to independently support quality engineering activities with minimal supervision, including process control, validation, testing, inspection, supplier quality, and regulatory documentation. This role will lead quality improvement initiatives, evaluate production processes, analyze sources of variation, and develop solutions that improve product quality and reduce defects and failures.The Senior Quality Engineer will also provide Quality expertise across Product Development, Design Control, Risk Management, supplier management, and regulatory activities. The role requires strong analytical and problem-solving skills, the ability to manage multiple projects, and experience working cross-functionally in a regulated quality environment.Key ResponsibilitiesDevelop and implement methods and procedures for process control, process validation, process improvement, testing, and inspection.Evaluate production processes and recommend improvements to maintain product quality and functionality.Design complex experiments to identify sources of variation affecting products and processes.Apply Statistical Process Control (SPC) methods to analyze data and evaluate processes and process changes.Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.Generate and analyze reports and defective products to identify trends and lead corrective actions.Apply probability and statistical quality control concepts to support quality decisions.Collaborate with supplier representatives to resolve quality problems and ensure effective corrective actions.Lead and support supplier corrective actions, including CAPA and SCAR activities.Lead supplier qualification activities and contribute to supplier quality improvement programs.Provide Quality expertise for Product Development and Design Control activities.Support Risk Management and CE Technical File activities.Generate and maintain Device Master Records (DMRs), product specifications, design control files, and CE Technical Files.Work with Regulatory teams and suppliers on 510(k) submissions, letters to file, and related documentation as required.Coordinate product testing with internal and external laboratories.Ensure compliance with applicable domestic and international regulations for assigned products and processes.Perform quality reviews of design documentation, vendor quality documents, and company quality records.Lead investigations of product and process non-conformances and out-of-specification results.Develop and implement effective corrective and preventive actions (CAPA).Train and coach team members and Medline employees on applicable processes and best practices as needed.Act as the Quality lead in the absence of Quality Management.Required QualificationsBachelor's degree in Engineering, Science, Mathematics, or another related technical field.4+ years of experience in Quality or Engineering.Experience applying government and industry quality assurance codes and standards, including applicable examples such as 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.Ability to work independently, accomplish objectives with limited supervision, and determine when escalation is necessary.Strong time management skills with the ability to prioritize, organize, and track multiple projects and deadlines.Demonstrated problem-solving ability using mathematical or systematic approaches.Experience leading a team to accomplish cross-functional goals.Experience with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.Advanced Microsoft Excel skills, including pivot tables, pivot reporting, conditional formatting, tables, formulas, and charting.Ability to travel up to 15%.Preferred Qualifications5+ years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.Knowledge of advanced Six Sigma and Lean concepts.Skills & CompetenciesQuality EngineeringQuality AssuranceProcess ControlProcess ValidationProcess ImprovementProduct TestingInspectionStatistical Process Control (SPC)Statistical Quality ControlExperimental DesignData AnalysisRoot Cause AnalysisCorrective and Preventive Action (CAPA)Supplier Corrective Action Request (SCAR)Supplier Quality ManagementSupplier QualificationProduct DevelopmentDesign ControlRisk ManagementRegulatory ComplianceMedical Device QualityDevice Master Records (DMR)CE Technical Files510(k) SubmissionsNon-Conformance InvestigationOut-of-Specification InvestigationQuality DocumentationMicrosoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft OutlookCross-Functional LeadershipTeam LeadershipTraining and CoachingProblem-solvingTime ManagementProject ManagementEducation & ExperienceEducation:Bachelor's degree in Engineering, Science, Mathematics, or another related technical field.Experience:4+ years of experience in Quality or Engineering.5+ years of industry experience in Medical Devices, Drugs, or directly related fields is preferred.Experience with applicable government and industry quality assurance standards is required.Work Arrangement & ScheduleLocation: Chicago, Illinois, United StatesWork Arrangement: OnsiteEmployment Type: Not specified in the original job descriptionWeekly Hours: Not specifiedTravel: Up to 15%Weekend Requirements: Not specifiedCompensation & BenefitsAnticipated Salary Range: $101,000–$152,000 per yearBonus and/or incentive eligible.Health insuranceLife insuranceDisability benefits401(k) contributionsPaid time offContinuing education and trainingEmployee Resource GroupsEmployee Service Corp.Additional total rewards opportunitiesThe actual salary may vary based on location, education, experience, skills, and abilities.Compliance / Additional InformationMedline Industries, LP and its subsidiaries are Equal Opportunity Employers. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.This position involves quality activities within regulated product and manufacturing environments and requires compliance with applicable domestic and international regulations and quality standards.","datePosted":"2026-08-27T09:55:40.837Z","dateModified":"2026-08-27T09:55:40.837Z","hiringOrganization":{"@type":"Organization","name":"Torentify","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Chicago","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b7eb6c9f2bfd205fe3f0e6b2"},"url":"https://jobsearcher.com/jobs/b7eb6c9f2bfd205fe3f0e6b2"}}