Sr. Quality Engineer

1 week ago


Winnetka, United States Medline Industries Full time

JOB SUMMARY:Under minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.MAJOR RESPONSIBILITIES:Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional. Design complex experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process 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 determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required. Coordinate product testing with internal and external laboratories as required.Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).May train and coach team members and Medline employees on appropriate processes and best practices.EducationTypically requires a Bachelor's degree in Engineering, Science, Math or other related technical field.Work ExperienceAt least 4 years of experience in the Quality or Engineering.Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).Knowledge / Skills / AbilitiesExperience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary. Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations.Experience leading a team to accomplish cross-functional goals.Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook).Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).Position requires up to 15% travel.PREFERRED JOB REQUIREMENTSAt least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.Knowledge of advanced Six Sigma/Lean concepts.


  • Quality Engineer

    4 weeks ago


    Winnetka, United States Collabera Full time

    Description Home Search Jobs Job Description Quality EngineerContract: Northfield, Illinois, USSalary: $45.00 Per HourJob Code: 349868End Date: 2024-06-27 Days Left: 27 days, 3 hours leftApplyAbout the Role: We are looking for a Quality Engineer to join our team and work on multi-disciplinary team planning and ecosystem integration to accelerate delivery and...

  • Quality Engineer

    4 weeks ago


    Winnetka, United States Collabera Full time

    Description Home Search Jobs Job Description Quality EngineerContract: Northfield, Illinois, USSalary: $45.00 Per HourJob Code: 349868End Date: 2024-06-27 Days Left: 27 days, 3 hours leftApplyAbout the Role: We are looking for a Quality Engineer to join our team and work on multi-disciplinary team planning and ecosystem integration to accelerate delivery and...


  • Winnetka, United States Medline Industries Full time

    Sr. Full-Stack Software Engineer Job Overview: Medline Industries is seeking a talented Full-Stack Software Engineer to join our Software Engineering organization, helping to modernize Medline systems using modern architecture and technologies to improve efficiency, productivity, and availability. The ideal candidate will have a strong background in software...


  • Winnetka, United States Medline Industries Full time

    Sr. Full-Stack Software Engineer Job Overview: Medline Industries is seeking a talented Full-Stack Software Engineer to join our Software Engineering organization, helping to modernize Medline systems using modern architecture and technologies to improve efficiency, productivity, and availability. The ideal candidate will have a strong background in software...

  • Quality Engineer

    4 weeks ago


    Winnetka, United States Collabera Full time

    Description Home Search Jobs Job Description Quality Engineer Contract: Northfield, Illinois, US Salary: $45.00 Per Hour Job Code: 349981 End Date: 2024-06-28 Days Left: 28 days, 3 hours left Apply Position: Quality Engineering Lead Location: Northfield, IL Duration: 8+ months Responsibility: Apply business and functional knowledge to develop testing...

  • Quality Engineer

    2 days ago


    Winnetka, United States Collabera Full time

    Description Home Search Jobs Job Description Quality Engineer Contract: Northfield, Illinois, US Salary: $45.00 Per Hour Job Code: 349981 End Date: 2024-06-28 Days Left: 3 hours left Apply Position: Quality Engineering Lead Location: Northfield, IL Duration: 8+ months Responsibility: Apply business and functional knowledge to develop testing...

  • Quality Engineer

    2 weeks ago


    Winnetka, United States Collabera Full time

    Description Home Search Jobs Job Description Quality EngineerContract: Northfield, Illinois, USSalary: $45.00 Per HourJob Code: 349981End Date: 2024-06-28 Days Left: 11 days, 3 hours leftApplyPosition: Quality Engineering LeadLocation: Northfield, ILDuration: 8+ monthsResponsibility: Apply business and functional knowledge to develop testing strategies...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY: Under broad supervision, responsible for independently setting basic quality standards for both textiles finished goods and textiles manufacturing processes while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY: Under broad supervision, responsible for independently setting basic quality standards for both textiles finished goods and textiles manufacturing processes while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain...

  • Quality Engineer

    1 week ago


    Winnetka, United States Medline Industries Full time

    JOB SUMMARY:Under broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control...

  • Quality Specialist

    2 weeks ago


    Winnetka, Illinois, United States Medline Industries Full time

    JOB SUMMARY This role specializes in one or two particular subsection(s) of our Quality Management System (e.g. Device Master Records, customer complaint, product hold, recalls, incoming quality).Responsible for basic building and maintaining quality documentation and processes such as product specifications, manufacturing tolerances, engineering drawings,...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY: Responsible for providing basic quality support to the Division including complaint investigation, resolution, and reporting. Assist with routine product evaluations, set basic quality standards for both in-process and finished product inspections, and support the QA team in product testing, documentation, and vendor qualification activities....


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY: Responsible for providing basic quality support to the Division including complaint investigation, resolution, and reporting. Assist with routine product evaluations, set basic quality standards for both in-process and finished product inspections, and support the QA team in product testing, documentation, and vendor qualification activities. ...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY: Responsible for providing basic quality support to the Division including complaint investigation, resolution, and reporting. Assist with routine product evaluations, set basic quality standards for both in-process and finished product inspections, and support the QA team in product testing, documentation, and vendor qualification activities. ...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARYResponsible for managing the quality and compliance for applicable products and processes for assigned department(s).Adapt departmental plans and priorities to address resource and operational challenges.MAJOR RESPONSIBILITIESEnsure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life...


  • Winnetka, United States Medline Industries Full time

    JOB SUMMARY Responsible for managing the quality and compliance for applicable products and processes for assigned department(s).Adapt departmental plans and priorities to address resource and operational challenges. MAJOR RESPONSIBILITIES Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable...

  • Full Stack Engineer

    2 weeks ago


    Winnetka, United States Medline Industries Full time

    Medline Industries is seeking a talented Full-Stack Software Engineer to join our Software Engineering organization, helping to modernize Medline systems using modern architecture and technologies to improve efficiency, productivity, and availability. The ideal candidate will have a strong background in software engineering and experience with modern...

  • Associate Engineer

    1 month ago


    Winnetka, United States Medline Industries Full time

    With fifty years of consecutive growth, Medline has more than 25,000 employees worldwide and business in more than 90 countries. Recently named one of the nation's "Best and Brightest Companies to Work for," this position is based out of our corporate office in Northfield, IL. To maintain this enviable position and continue our growth, we are looking for new...

  • Associate Engineer

    4 weeks ago


    Winnetka, United States Medline Industries Full time

    With fifty years of consecutive growth, Medline has more than 25,000 employees worldwide and business in more than 90 countries. Recently named one of the nation's "Best and Brightest Companies to Work for," this position is based out of our corporate office in Northfield, IL. To maintain this enviable position and continue our growth, we are looking for new...

  • Associate Engineer

    3 weeks ago


    Winnetka, United States Medline Industries Full time

    With fifty years of consecutive growth, Medline has more than 25,000 employees worldwide and business in more than 90 countries. Recently named one of the nation's "Best and Brightest Companies to Work for," this position is based out of our corporate office in Northfield, IL. To maintain this enviable position and continue our growth, we are looking for new...