Engineer Quality

Medline; Chicago, Northern (IL, KY); Hybrid; USD 79,000 - 119,000; Full time

Job summary

Medline is seeking a Quality Engineer to independently set basic quality standards for in-process activities and lead testing, sampling, and training initiatives in a hybrid role based in Chicago, IL. You will evaluate production processes, design experiments, and apply SPC to drive improvements while maintaining CE, 510K, and other regulatory documentation.

You will collaborate with suppliers, manage CAPA/SCAR actions, and build robust product documentation (DMRs, design history, and risk

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Intermediate skill level in Microsoft Excel.
• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
• Position requires up to 15% travel.

Responsibilities

• Develop and implement methods and procedures for process control, validation, testing, and inspection.
• Design experiments to understand sources of variation and apply SPC to evaluate processes.
• Lead supplier qualifications and collaborate with suppliers on CAPA/SCAR.
• Prepare and maintain Design Control files, DMRs, and CE technical files.
• Coordinate product testing with internal and external laboratories as required.

Skills

MS Office

Time management

Problem solving

Education

Bachelor's degree in Engineering, Science, or Math

Tools

MS Excel

21 CFR 820

ISO 13485

Job description

## Engineer QualityApply: Hybrid: Chicago, Illinois: Full time: Posted Today: R2619043**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 files, and CE technical files.**Job Description****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 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 corrective action implementation (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). **MINIMUM JOB REQUIREMENTS:****Education:*** Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.**Certification / Licensure:*** None**Work Experience:*** At least 2 years of experience in the Quality or Engineering.**Knowledge / Skills / Abilities:*** Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues 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 using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).* Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)* Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).* Position requires up to 15% travel **PREFERRED JOB REQUIREMENTS:****Education:*** None**Certification / Licensure:*** None**Work Experience:*** At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.**Knowledge / Skills / Abilities:*** NoneMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.The anticipated salary range for this position:$79,000.00 - $119,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.