Quality Engineer II: Validation & Compliance

Becton, Dickinson and Company; Cockeysville (MD); Presencial; USD 76.000 - 121.000; Jornada completa

Descripción de la vacante

BD is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing plants with a focus on validation writing and execution.

You will partner cross-functionally to ensure regulatory compliance, drive continuous improvement, and lead investigations when required. The role requires a Bachelor's in a related science and 2 years of Quality or Engineering experience.

Formación

• Bachelor's degree in Biological Sciences, Chemistry, or related science field.
• 2 years experience in Quality, Scientific Operations, or Engineering.
• Experience with technical writing and process/test method validations is preferred.

Responsabilidades

• Develop, implement, and maintain Quality System procedures, SOPs, and quality policies.
• Lead and execute validation activities, including change validations and qualifications for Media plants and IDAST.
• Monitor, trend, and analyze quality indicators for materials, products, and components.
• Assess CTQ parameters and perform risk assessments to support product quality and process reliability.
• Apply statistical tools to identify root causes and implement corrective actions.
• Initiate and support CAPAs and investigations when required.
• Support process control initiatives and promote consistent manufacturing practices.
• Identify and implement opportunities to improve product quality and efficiency.
• Manage day-to-day QM Engineering activities for assigned products and projects.
• Collaborate with manufacturing, engineering, and cross-functional teams on product launches and quality initiatives.
• Ensure QMS compliance for new and existing product lines.
• Maintain FDA/ISO regulatory compliance and participate in audits.

Conocimientos

Quality systems

Validation writing

Statistical analysis

CAPA management

Root cause analysis

Documentation

Cross-functional teamwork

FDA/ISO knowledge

Educación

Bachelor's degree in Biological Sciences or related field

Herramientas

SPC

Six Sigma

Quality systems software

Descripción del empleo

BD is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing plants with a focus on validation writing and execution.

You will partner cross-functionally to ensure regulatory compliance, drive continuous improvement, and lead investigations when required. The role requires a Bachelor's in a related science and 2 years of Quality or Engineering experience.