Quality Engineer I: FDA/ISO Compliance & CAPA Specialist

Becton Dickinson NA; Carol Stream (IL); On-site; USD 76,000 - 121,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

BD in Illinois, Carol Stream, seeks a Quality Engineer to support FDA QMSR, ISO 13485, and EU MDR compliance, including CAPA, NCMRs, design controls, and DHF documentation. The role emphasizes quality system investigations, environmental monitoring, calibration reviews, risk assessments (FMEA/FTA), audits, and continuous improvement in manufacturing and lab environments.

Bachelor’s degree in a scientific field and 0–2 years in a regulated setting are preferred; strong English communication and

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.
• Demonstrated understanding of problem solving data analysis, investigations, and quality system concepts.

Responsibilities

• Supports FDA QMSR, ISO 13485, and EU MDR compliance activities.
• Owns quality system investigations and associated actions (complaints, NCMRs, CAPAs, audits).
• Maintains and reviews Quality System Documents and DHF materials.
• Develops and maintains risk assessments (FMEA/FTA) with guidance.
• Supports internal and supplier quality audits and continuous improvement initiatives.

Skills

Quality systems

Regulatory knowledge

Problem solving

English communication

Education

Bachelor's degree in a scientific discipline

Tools

Minitab

Microsoft Office

Visio

Excel

Job description

BD in Illinois, Carol Stream, seeks a Quality Engineer to support FDA QMSR, ISO 13485, and EU MDR compliance, including CAPA, NCMRs, design controls, and DHF documentation. The role emphasizes quality system investigations, environmental monitoring, calibration reviews, risk assessments (FMEA/FTA), audits, and continuous improvement in manufacturing and lab environments.

Bachelor’s degree in a scientific field and 0–2 years in a regulated setting are preferred; strong English communication and