Quality Engineer, Medical Devices: Validation & Compliance

Becton Dickinson; Riverside Park (NJ); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Becton Dickinson seeks a Quality Engineer for its Delran, New Jersey manufacturing facility. The role involves developing quality documentation, leading validation activities, investigating quality issues, and ensuring compliance with regulatory standards for medical device production.

The position requires a Bachelor's degree in Biomedical Engineering or related field, 3+ years of quality engineering experience in medical devices or manufacturing, and strong skills in statistics (Minitab) and

Formación

• Bachelor's degree in Biomedical Engineering or related field.
• 3+ years quality engineering experience in medical devices or manufacturing.
• Knowledge of FDA QSR and ISO 13485 standards.
• Proficiency with statistical software such as Minitab and MS Excel.
• Strong oral and written communication skills.
• Project planning skills and ability to meet customer needs.

Responsabilidades

• Author, review, and approve quality management system documents and records.
• Lead validation activities including protocol development for new products and process improvements.
• Design and conduct quality studies to identify root causes and drive process improvements.
• Investigate quality issues, initiate nonconformance reports, and manage Material Review Board processes.
• Review and approve inspection records, environmental monitoring data, and Lot History Records for compliance.

Conocimientos

Quality engineering

Project planning

Communication

Educación

Bachelor's degree in Biomedical Engineering

Herramientas

Minitab

MS Excel

Descripción del empleo

Becton Dickinson seeks a Quality Engineer for its Delran, New Jersey manufacturing facility. The role involves developing quality documentation, leading validation activities, investigating quality issues, and ensuring compliance with regulatory standards for medical device production.

The position requires a Bachelor's degree in Biomedical Engineering or related field, 3+ years of quality engineering experience in medical devices or manufacturing, and strong skills in statistics (Minitab) and