Quality Engineer- Anesthesia

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

Job summary

Medline in Chicago is seeking a Quality Engineer to lead development and enforcement of quality standards for anesthesia-related products. Hybrid schedule, full-time.

You will design experiments, apply SPC, manage supplier qualifications, CAPA, and build device master records while ensuring regulatory compliance (21 CFR 820, ISO13485). Travel up to 15%.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related field.
• 2+ years of experience in Quality or Engineering.
• Knowledge of 21 CFR 820, ISO13485 and regulatory requirements.
• Up to 15% travel.

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection.
• Design experiments to understand variation and apply SPC.
• Generate and analyze reports on defects and lead corrective actions.
• Lead supplier qualifications and CAPA activities.
• Create and maintain device master records and regulatory documents.
• Coordinate product testing with labs and ensure regulatory compliance.

Skills

SPC

DOE

CAPA

Vendor management

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Engineering, Science, Math or related field

Tools

MS Office

Excel

Job description

## Quality Engineer- AnesthesiaApply: Hybrid: Chicago, Illinois: Full time: Posted Today: R2615740**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).**Education:*** Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.**Work Experience:*** 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:*** 2+ years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.Medline 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.