Quality Engineer: Process Control & CAPA Lead

Regulatory Jobs; Chicago (IL); Presencial; USD 79 000 - 119 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Life and disability

401(k) contributions

Paid time off

Resumo da oferta

Medline Industries, LP seeks a quality professional to set basic quality standards and lead methods for testing, sampling and training. You will evaluate production processes, justify improvements, manage vendors, generate DMRs, product specs and CE technical files.

Responsibilities include applying SPC, designing experiments, CAPA, SCAR, and building documentation to comply with 21 CFR 820/ISO13485. Travel up to 15% may be required, with a competitive benefits package.

Qualificações

• Experience applying SPC to analyze data and guide process changes.
• Experience building device master records and design history files.
• Familiarity with 21 CFR 820 and ISO13485 quality systems.

Responsabilidades

• Manage methods for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation and guide decisions.
• Lead CAPA/SCAR and supplier quality improvement programs.
• Develop and maintain QMS documentation for regulatory submissions.
• Coordinate product testing with internal/external labs and ensure compliance.
• Lead investigations of non-conformances and implement effective corrective actions.

Conhecimentos

SPC analysis

Quality Assurance

Vendor management

CAPA

Regulatory knowledge

MS Office

Process control

Formação académica

Bachelor’s degree in Engineering/Science

Descrição da oferta de emprego

Medline Industries, LP seeks a quality professional to set basic quality standards and lead methods for testing, sampling and training. You will evaluate production processes, justify improvements, manage vendors, generate DMRs, product specs and CE technical files.

Responsibilities include applying SPC, designing experiments, CAPA, SCAR, and building documentation to comply with 21 CFR 820/ISO13485. Travel up to 15% may be required, with a competitive benefits package.