Quality Engineer - Medical Devices | Validation & Compliance

Becton Dickinson; Fairview (NJ); Presencial; USD 80.000 - 110.000; 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.

Responsibilities include authoring QMS documents, leading validation protocols, and driving process improvements through rigorous data analysis and MRB management.

Formación

• Bachelor's degree in Biomedical Engineering or related field is required.
• 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

FDA QSR knowledge

Statistical software

Communication skills

Project planning

Root cause analysis

Educación

Bachelor's degree in Biomedical Engineering or related field

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.

Responsibilities include authoring QMS documents, leading validation protocols, and driving process improvements through rigorous data analysis and MRB management.