Quality Engineer I – MedTech, FDA/ISO Compliance

Becton Dickinson; Carol Stream (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Becton Dickinson (BD) seeks a Quality Engineer to support regulatory-compliant quality systems across FDA, ISO, and EU MDR frameworks. The role covers CAPA, investigations, and DHF maintenance in a regulated medical device setting.

The ideal candidate has a bachelor’s degree in a scientific field and up to 2 years of experience, with strong problem-solving and data analysis skills. Collaboration and precise documentation are essential.

Qualifications

• Bachelor's degree in a scientific discipline (Engineering, Engineering Technology, Chemical, Biological, or equivalent).
• 0–2 years of experience in the medical device, pharmaceutical, or other regulated industry.
• Internship, co-op, academic, laboratory, or industry experience supporting quality, validation, manufacturing, engineering, or regulatory activities.

Responsibilities

• Supports and executes compliance activities for QMSR/ISO 13485 and EU MDR.
• Owns quality system investigations and CAPA processes to completion.
• Maintains Quality System Documents and Design History File (DHF).
• Administers Environmental Monitoring Program and data review.
• Performs calibration-related activities and maintains documentation.
• Supports Design Transfer and manufacturing process improvements.
• Participates in Internal and Supplier Quality System Audits.

Skills

Strong communication

Team collaboration

Problem solving

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

Minitab

Microsoft Excel

Visio

Job description

Becton Dickinson (BD) seeks a Quality Engineer to support regulatory-compliant quality systems across FDA, ISO, and EU MDR frameworks. The role covers CAPA, investigations, and DHF maintenance in a regulated medical device setting.

The ideal candidate has a bachelor’s degree in a scientific field and up to 2 years of experience, with strong problem-solving and data analysis skills. Collaboration and precise documentation are essential.