Quality Engineer I - MedTech Quality & CAPA

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

Benefits offered by this job

Health & Wellness benefits

401(k) and financial planning

Paid time off

Job summary

BD in the United States (Illinois) seeks a Quality Engineer to support FDA QMSR, ISO 13485, EU MDR, design controls, validation, CAPA, and investigations. You will own quality system actions, audits, and documentation while collaborating with project teams in a fast-paced environment.

The role requires a bachelor’s in a scientific field with 0–2 years in regulated industries, plus strong problem solving, data analysis, and English communication skills.

Qualifications

• Bachelor's degree in Engineering or 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 in quality, validation, manufacturing, engineering, or regulatory activities.
• Demonstrated understanding of problem solving data analysis, investigations, and quality system concepts.

Responsibilities

• Supports and executes compliance activities related to FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR 2017/745, Design Controls, Validation/Qualification, and CAPA processes.
• Owns quality system investigations and actions (complaints, NCMRs, CAPAs, audit responses, failure investigations).
• Ensures compliance with Department and Business Unit procedures and supports adherence to quality system requirements.
• Owns and executes quality engineering deliverables in support of project team and quality objectives.
• Administers Environmental Monitoring Program including data review, trending, investigation support, and documentation.
• Performs calibration-related activities and reviews required documentation.
• Creates, reviews, and maintains Quality System Documents, DHF, and Product Documents.
• Develops and executes protocols, validation activities, equipment qualifications, and test methods.
• Maintains risk assessments (FMEA/FTA) with guidance.
• Participates in Internal and Supplier Quality System Audits and drives audit actions.
• Supports Design Transfer activities, equipment introductions, and manufacturing process improvements.
• Manages continuous improvement initiatives and action plans.
• Maintains awareness of industry developments through training and quality-related development.
• Maintains compliance with safety standards, quality requirements, procedures, and site policies.

Skills

MS Office

Minitab

Regulatory knowledge

Lean Six Sigma

English communication

Problem solving

Teamwork

Time management

Data interpretation

Statistics basics

Presentation skills

Mathematics

Education

Bachelor's degree in Engineering or scientific field

Tools

Visio

Job description

BD in the United States (Illinois) seeks a Quality Engineer to support FDA QMSR, ISO 13485, EU MDR, design controls, validation, CAPA, and investigations. You will own quality system actions, audits, and documentation while collaborating with project teams in a fast-paced environment.

The role requires a bachelor’s in a scientific field with 0–2 years in regulated industries, plus strong problem solving, data analysis, and English communication skills.