Quality Engineer - Medical Devices, CE/510K Focus

Regulatory Jobs; Chicago (IL); Ibrido; USD 79.000 - 119.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) contributions

Paid time off

Descrizione del lavoro

Medline Industries, LP in Chicago seeks a Quality/Engineering professional to set basic quality standards, design control files, and manage vendor qualifications. You will develop testing methods, sampling plans, and training for manufacturing processes.

Responsibilities include SPC analysis, CAPA, 510K submissions coordination with Regulatory Groups and suppliers, and ensuring compliance with 21 CFR 820 and ISO13485. Travel up to 15%.

Competenze

• Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
• Experience developing ways of accomplishing goals with little supervision and escalation when needed.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).

Mansioni

• Develop and implement methods for process control, validation, testing and inspection.
• Design and perform experiments and analyze data using SPC to evaluate processes.
• Lead supplier qualifications and CAPA activities to improve supplier quality.
• Prepare Device Master Records and 510K submissions with Regulatory Groups and Suppliers.
• Ensure compliance with 21 CFR 820 and ISO13485; conduct design reviews and risk assessments.
• Lead investigations of non-conformances and drive corrective actions.

Conoscenze

SPC

CAPA

Quality Assurance

Process Validation

Design Control

Vendor Management

Documentation

MS Office

Excel

Problem Solving

Formazione

Bachelor's degree in Engineering

Strumenti

MS Office

Statistical software

Descrizione del lavoro

Medline Industries, LP in Chicago seeks a Quality/Engineering professional to set basic quality standards, design control files, and manage vendor qualifications. You will develop testing methods, sampling plans, and training for manufacturing processes.

Responsibilities include SPC analysis, CAPA, 510K submissions coordination with Regulatory Groups and suppliers, and ensuring compliance with 21 CFR 820 and ISO13485. Travel up to 15%.