Quality Engineer - Medical Devices, CAPA & Compliance

Medline Industries, Inc.; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead development efforts for testing, sampling, and training. You will evaluate production processes, recommend improvements, qualify vendors, and maintain DMRs, product specifications, and CE technical files.

The role requires coordinating with regulatory groups, performing CAPA investigations, and ensuring compliance with 21 CFR 820 and ISO13485. Travel up to 15% is expected.

Qualifications

• At least 2 years of experience in Quality or Engineering.
• Experience in Medical Devices, Drugs, or related fields (2+ years).
• Ability to develop CAPA, SCAR, and vendor management documentation.
• Familiarity with 21 CFR 820 and ISO13485.

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection to ensure products are ideal and functional.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates; generate reports to identify trends and lead CAPA actions.
• Direct and collaborate with supplier representatives on quality problems; ensure corrective action implementation and supplier quality improvement programs.
• Provide Quality expertise in Product Development, Design Control, Risk Management, and CE Technical Files; build device master records and support 510K submissions and letters to file.
• Coordinate product testing with internal and external laboratories and ensure compliance with regulations across product lines.
• Lead investigations of non-conformances and out-of-spec results and develop corrective and preventive actions (CAPA).

Skills

Problem solving

Time management

Independent work

Attention to detail

Regulatory awareness

Travel up to 15%

Education

Bachelor's degree in Engineering, Science or related field

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP is seeking a quality professional to set basic in-process quality standards and lead development efforts for testing, sampling, and training. You will evaluate production processes, recommend improvements, qualify vendors, and maintain DMRs, product specifications, and CE technical files.

The role requires coordinating with regulatory groups, performing CAPA investigations, and ensuring compliance with 21 CFR 820 and ISO13485. Travel up to 15% is expected.