Quality Engineer (MedTech) - SPC, CAPA & Design Control

Regulatory Jobs

Chicago (IL)

On-site

USD 79,000 - 119,000

Full time

2 days ago

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Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP seeks aQuality professional to set basic quality standards for in-process work and lead methods for testing, sampling, and training. Responsible for process evaluation, vendor management, DMRs, product specs, design control files, and CE technical files.

The role involves applying SPC to analyze data, leading CAPA actions, and coordinating supplier quality improvement programs. Travel up to 15% may be required.

Qualifications

Bachelor's degree in Engineering, Science, Math or related technical field.
2+ years of experience in Quality or Engineering.
Knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).

Responsibilities

Set and maintain quality standards for in-process and testing activities.
Apply SPC methods to analyze data and guide process improvements.
Design and perform product testing and analysis; lead CAPA actions and report trends.
Coordinate supplier quality activities and qualification programs.
Develop and maintain device master records and CE technical files for regulatory submissions.
Support design controls, risk management, and regulatory documentation.

Skills

SPC analysis

Process control

CAPA

Documentation

MS Office Suite

Analytical skills

Education

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

Job description

The role involves applying SPC to analyze data, leading CAPA actions, and coordinating supplier quality improvement programs. Travel up to 15% may be required.

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