Quality Engineer: Medical Devices, CAPA & Compliance

Medline Industries, Inc.; Chicago (IL); Sur place; USD 79 000 - 119 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life and disability

401(k)

Résumé du poste

Medline Industries, LP is seeking a Quality Engineer to establish basic quality standards for in-process work and lead method development for testing, sampling, and training. You will evaluate production processes, qualify vendors, generate DMRs and CE files.

Responsibilities include SPC analysis, experimental testing, CAPA with suppliers, risk management, and 510K submissions while ensuring compliance with 21 CFR 820 and ISO 13485. Up to 15% travel required. Salary range shown below.

Qualifications

• Bachelor's degree in engineering, science, math or related field.
• At least 2 years of experience in Quality or Engineering.
• Experience with SPC, process validation, and CAPA.
• Knowledge of 21 CFR 820 and ISO 13485.
• Travel up to 15%.

Responsabilités

• Develop and implement methods for process control, validation, testing and inspection.
• Apply SPC to analyze data and evaluate processes and changes.
• Lead supplier quality improvements and supplier qualifications.
• Prepare DMRs, Design History Files, and CE technical files.
• Coordinate product testing with internal and external labs; ensure regulatory compliance.
• Lead investigations of non-conformances and CAPA.

Connaissances

Autonomy

Time management

Problem solving

MS Office

Mid-level Excel

Quality standards (21 CFR 820, ISO 134

Travel up to 15%

Formation

Bachelor's degree in Engineering/Science/Math

Outils

MS Office Suite

Description du poste

Medline Industries, LP is seeking a Quality Engineer to establish basic quality standards for in-process work and lead method development for testing, sampling, and training. You will evaluate production processes, qualify vendors, generate DMRs and CE files.

Responsibilities include SPC analysis, experimental testing, CAPA with suppliers, risk management, and 510K submissions while ensuring compliance with 21 CFR 820 and ISO 13485. Up to 15% travel required. Salary range shown below.