Senior Quality Engineer — Project Leader

Medline Industries, Inc. in; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP in Chicago seeks a Senior Engineer Quality (Project Management) to set baseline quality standards, develop testing methods, sampling and training, while leading vendor management and creating DMRs and design control files.

We require 4+ years in quality/engineering, strong knowledge of 21 CFR 820, ISO13485, and related standards; travel up to 15% is expected. Salary range is $101,000–$152,000 with bonus eligibility and comprehensive benefits.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• 4+ years of experience in Quality or Engineering.
• Experience with government/industry quality codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO) preferred.
• Ability to work with minimal supervision and drive objectives.
• Strong time management and multitasking skills.
• Proven problem solving and cross-functional collaboration ability.
• Experience leading a team and MS Office proficiency.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments and apply SPC to analyze data and guide decisions.
• Lead CAPA/SCAR actions and supplier quality improvements.
• Provide quality expertise in product development, design control, risk management, and CE files.
• Coordinate device master records and 510K submissions with regulatory and suppliers.
• Direct product testing with internal/external labs and ensure regulatory compliance.

Skills

Advanced Excel

Leadership / Team leading

Time management

Problem solving

MS Office Suite

Statistical methods / SPC

CAPA / SCAR knowledge

Travel up to 15%

Education

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

Tools

Microsoft Excel

MS Office Suite tools

SPC tools

Job description

Medline Industries, LP in Chicago seeks a Senior Engineer Quality (Project Management) to set baseline quality standards, develop testing methods, sampling and training, while leading vendor management and creating DMRs and design control files.

We require 4+ years in quality/engineering, strong knowledge of 21 CFR 820, ISO13485, and related standards; travel up to 15% is expected. Salary range is $101,000–$152,000 with bonus eligibility and comprehensive benefits.