Hybrid: Senior Quality Engineer — CAPA & Process Control

Medline; Chicago (IL); Presencial; USD 101.000 - 152.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline in Chicago, IL seeks a Senior Engineer, Quality to set basic in‑process quality standards and lead testing, sampling and training efforts. You will evaluate production processes, design experiments and apply SPC to reduce defects and variation.

You will manage CAPA/SCAR with suppliers, maintain device master records and CE/510K-related documents, and guide regulatory submissions. Travel up to 15% is required.

Formación

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry quality standards (e.g., 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO sterilization).
• Experience leading cross-functional teams and CAPA/SCAR.
• Advanced Excel skills (Pivot tables, charts, formulas).

Responsabilidades

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand variation; apply SPC to evaluate processes.
• Lead supplier qualifications and CAPA/SCAR to drive quality improvements.
• Maintain DMRs, product specs, design control files and CE technical files.
• Coordinate testing with laboratories and regulatory submissions (510K).
• Investigate non-conformances and drive corrective actions; train team members.

Conocimientos

SPC methods

CAPA/SCAR

Supplier quality

Excel advanced

Project leadership

MS Office

Process control

Statistical analysis

Documentation (DMR)

Regulatory knowledge (FDA/ISO)

Educación

Bachelor’s degree in a technical field

Herramientas

Microsoft Excel

MS Office

Descripción del empleo

Medline in Chicago, IL seeks a Senior Engineer, Quality to set basic in‑process quality standards and lead testing, sampling and training efforts. You will evaluate production processes, design experiments and apply SPC to reduce defects and variation.

You will manage CAPA/SCAR with suppliers, maintain device master records and CE/510K-related documents, and guide regulatory submissions. Travel up to 15% is required.