Senior Quality Engineer — Medical Devices, Lead CAPA & SPC

Medline Industries, LP; Northfield (MN); Presencial; USD 101.000 - 152.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Life and disability

Descripción de la vacante

Medline Industries, LP is seeking an experienced Quality Engineer to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate processes, run experiments, and manage vendor quality with CAPA and SCAR programs.

You will also generate DMRs, device master records, design controls and CE files, coordinating with regulatory groups and suppliers to ensure compliance and continuous improvement across domestic and international regulations.

Formación

• Bachelor's degree in Engineering, Science, Math or related technical field.
• 4+ years of experience in Quality or Engineering.
• Experience with government/industry quality codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211).
• Ability to work independently with minimal supervision and escalate when needed.
• Strong time management to meet multiple project deadlines.
• Experience solving problems and leading cross-functional teams.
• Proficient with MS Office (Word, Excel, PowerPoint, Outlook).
• Advanced Excel skills (PivotTables, conditional formatting, charts).
• Up to 15% travel required.

Responsabilidades

• Develop and implement methods and procedures for process control, validation, testing, and inspection.
• Design experiments to understand variation sources affecting products/processes.
• Apply Statistical Process Control (SPC) for data analysis.
• Test and analyze product performance to maintain quality and reduce defects.
• Generate reports and analyze defective products to identify trends and CAPA actions.
• Lead supplier qualifications and collaborate on supplier quality improvements.
• Provide quality expertise in product development and risk management.
• Prepare product documentation in line with regulations (DMRs, design control, CE files).
• Coordinate testing with internal/external labs and regulatory submissions as needed.
• Ensure compliance with domestic/international regulations and conduct design/docs reviews.
• Lead investigations of non-conformances and implement CAPA.
• Mentor team members on processes and best practices.

Conocimientos

Statistical analysis

CAPA

SCAR

Supplier quality

Leadership

Cross-functional teamwork

MS Office

Excel advanced

Time management

Problem solving

Educación

Bachelor's degree in Engineering/Science/Math

Herramientas

MS Office Suite

Microsoft Excel

Descripción del empleo

Medline Industries, LP is seeking an experienced Quality Engineer to set basic quality standards and lead methods for testing, sampling, and training. You will evaluate processes, run experiments, and manage vendor quality with CAPA and SCAR programs.

You will also generate DMRs, device master records, design controls and CE files, coordinating with regulatory groups and suppliers to ensure compliance and continuous improvement across domestic and international regulations.