Senior Quality Engineer — Medical Devices (Wound Care)

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

Job summary

Medline Industries, LP is seeking a Quality/Engineering professional to independently set basic quality standards for in-process and development testing. You will lead methods for testing, sampling, and training, and manage DMRs, product specs, and CE files.

Responsibilities include CAPA, supplier qualifications, and regulatory compliance across domestic and international standards. The role requires 4+ years in Quality or Engineering, a Bachelor's in a technical field, and travel up to 15%.

Qualifications

• Bachelor's degree in engineering/science/math or related field.
• At least 4 years of experience in quality or engineering.
• Experience with government and industry quality standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO sterilization).
• Strong MS Excel and MS Office proficiency.
• Willingness to travel up to 15%.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, testing, and inspection to ensure products meet requirements.
• Design experiments and apply SPC to analyze data and guide process improvements.
• Lead CAPA and supplier quality initiatives, including supplier qualifications.
• Coordinate product testing with internal and external labs; maintain DMRs and design files.
• Provide QA expertise in product development, design controls, risk management, and CE technical files.
• Lead quality reviews of design documentation for regulatory compliance.

Skills

SPC methods

Cross-functional leadership

Time management

Problem solving

MS Office

Advanced Excel

Travel 15%

Education

Bachelor's degree

Job description

Medline Industries, LP is seeking a Quality/Engineering professional to independently set basic quality standards for in-process and development testing. You will lead methods for testing, sampling, and training, and manage DMRs, product specs, and CE files.

Responsibilities include CAPA, supplier qualifications, and regulatory compliance across domestic and international standards. The role requires 4+ years in Quality or Engineering, a Bachelor's in a technical field, and travel up to 15%.