Quality Engineer – Medical Devices, CAPA & Compliance

Medline Industries, Inc.

Northfield (MN)

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

Job summary

Medline Industries, LP seeks a qualified professional to independently set basic quality standards for in-process activities while leading method development for testing, sampling, and training. You will evaluate production processes, recommend improvements, qualify suppliers, and generate document sets including DMRs, product specs, and CE files.

The role requires a Bachelor’s degree in engineering or a related field and at least 2 years in Quality or Engineering.

Qualifications

Experience applying statistical methods to understand process variation.
Knowledge of CAPA/SCAR and supplier quality programs.
Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
Familiarity with government and industry quality codes (21 CFR 820, ISO13485).

Responsibilities

Set up and manage methods for process control, validation, improvement, testing, and inspection.
Design experiments to understand variation and apply SPC to evaluate changes.
Lead supplier quality activities, CAPA/SCAR investigations, and supplier qualifications.
Develop and maintain device master records and regulatory documentation (510K-related work as needed).
Ensure compliance with domestic and international regulations and conduct design reviews.