Quality Engineer I - Regulated MedTech QA & CAPA

Becton, Dickinson and Company; Carol Stream (IL); Presencial; USD 76 000 - 121 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k)

Paid time off

Parental leave

Educational assistance

Resumo da oferta

Becton, Dickinson, and Company (BD) is seeking a Quality Engineer to support compliance with FDA QMSR, ISO 13485, and EU MDR within a fast-paced medical device environment.

The role includes managing investigations, CAPAs, audits, and quality documentation, with exposure to CAPA, environmental monitoring, and design transfer activities. Strong problem-solving and teamwork are essential.

Qualificações

• Bachelor's degree in Engineering, Engineering Technology, Chemical, Biological, or equivalent.
• 0–2 years in regulated industry (medical device/pharma).
• Demonstrated ability to analyze data, investigate issues, and apply quality systems concepts.

Responsabilidades

• Supports and executes FDA QMSR, ISO 13485, EU MDR quality systems and CAPA processes.
• Owns quality system investigations, complaints, NCMRs, CAPAs, audits, and failure investigations.
• Performs environmental monitoring, calibration reviews, and maintains DHF/DQA documents.
• Leads design transfer activities, equipment introductions, and process improvements.
• Supports continuous improvement initiatives and quality-related training.

Conhecimentos

Microsoft Word

Microsoft Excel

Visio

PowerPoint

Minitab

Regulatory knowledge

Lean Six Sigma

English communication

Teamwork

Formação académica

Bachelor's degree in a scientific discipline

Descrição da oferta de emprego

Becton, Dickinson, and Company (BD) is seeking a Quality Engineer to support compliance with FDA QMSR, ISO 13485, and EU MDR within a fast-paced medical device environment.

The role includes managing investigations, CAPAs, audits, and quality documentation, with exposure to CAPA, environmental monitoring, and design transfer activities. Strong problem-solving and teamwork are essential.