Senior Quality Engineer: Process Control & CAPA

Medline Industries, LP; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality-focused professional to independently set basic in-process quality standards and lead efforts to develop testing methods, sampling plans, and training programs. You will evaluate production processes, qualify vendors, and maintain DMRs and device master records to support CE and regulatory requirements.

The role requires at least 4 years in Quality or Engineering with strong knowledge of 21 CFR 820, ISO13485, and related standards.

Qualifications

• Bachelor’s degree in engineering, science, math or related technical field.
• At least 4 years of experience in Quality or Engineering with knowledge of government/industry quality codes.

Responsibilities

• Set basic in-process quality standards and lead testing, sampling, and training development.
• Design complex experiments and apply SPC to analyze data and guide process changes.
• Lead CAPA/SCAR investigations and supplier qualifications.
• Prepare and maintain DMRs, product specifications, design control files, and CE technical files.
• Coordinate design reviews, vendor testing, and regulatory submissions as required.
• Provide quality expertise in development and risk management across design controls.

Skills

Quality engineering

Process improvement

SPC analysis

CAPA/SCAR

Regulatory compliance

MS Office

Advanced Excel

Team leadership

Time management

Problem solving

Education

Bachelor’s degree in Engineering/Science/Math

Tools

21 CFR 820

ISO 13485

21 CFR 210/211

MDD/MDR

ANSI/AAMI/ISO sterilization standards

Job description

Medline Industries, LP is seeking a quality-focused professional to independently set basic in-process quality standards and lead efforts to develop testing methods, sampling plans, and training programs. You will evaluate production processes, qualify vendors, and maintain DMRs and device master records to support CE and regulatory requirements.

The role requires at least 4 years in Quality or Engineering with strong knowledge of 21 CFR 820, ISO13485, and related standards.