Senior Quality Engineer - Medical Devices & Compliance

Regulatory Jobs; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Professional to independently set basic quality standards and lead methods for testing, sampling, and training. You will manage process control, SPC analyses, and design of experiments to improve product quality and compliance with CE/21 CFR standards.

The role involves cross-functional leadership, CAPA, supplier qualifications, and building Device Master Records.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry quality codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).
• Ability to design experiments and apply SPC for data analysis.
• Strong problem-solving, leadership, and cross-functional collaboration skills.
• Proficiency with MS Office and advanced Excel (Pivot tables, conditional formatting).
• Willingness to travel up to 15%.

Responsibilities

• Manage development and implementation of methods for process control, validation, and inspection.
• Design experiments to study variation and apply SPC to analyze data.
• Perform product testing and analysis to maintain quality and reduce defects.
• Lead CAPA and supplier qualifications; collaborate with supplier representatives.
• Provide quality expertise in design control, risk management, and CE documentation.
• Ensure regulatory compliance for domestic/international product lines and records.
• Lead investigations of non-conformances and develop corrective actions.
• Mentor team members on processes and best practices; act as Quality lead when needed.

Skills

Quality mindset

Statistical analysis

CAPA management

SPC (Statistical Process Control)

Leadership

Project management

MS Office

Advanced Excel

Communication

Time management

Education

Bachelor’s degree in Engineering, Science, Math or related technical field

Tools

MS Office Suite

Excel

Job description

Medline Industries, LP is seeking a Quality Professional to independently set basic quality standards and lead methods for testing, sampling, and training. You will manage process control, SPC analyses, and design of experiments to improve product quality and compliance with CE/21 CFR standards.

The role involves cross-functional leadership, CAPA, supplier qualifications, and building Device Master Records.