Quality Engineer I

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

Benefits offered by this job

Health insurance

401(k)

Paid time off

Parental leave

Educational assistance

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Microsoft Word

Microsoft Excel

Visio

PowerPoint

Minitab

Regulatory knowledge

Lean Six Sigma

English communication

Teamwork

Education

Bachelor's degree in a scientific discipline

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description Essential / Key Job Responsibilities

Supports and executes compliance activities related to the Food and Drug Administration (FDA) Quality Management System Regulation (QMSR) (21 CFR Part 820), International Organization for Standardization (ISO) 13485, European Union Medical Device Regulation (EU MDR 2017/745), Design Controls, Validation/Qualification activities, and Corrective and Preventive Action (CAPA) processes through implementation and monitoring of quality system procedures. Owns assigned quality system investigations and associated actions, including complaints, Nonconforming Material Reports (NCMRs), CAPAs, audit responses, and failure investigations, and drives activities through completion. Ensures compliance with Department and Business Unit procedures and supports adherence to applicable quality system requirements. Owns and executes assigned quality engineering deliverables in support of Project Team and Quality Department objectives. Administers the Environmental Monitoring Program, including monitoring activities, data review, trending, investigation support, and associated documentation. Performs calibration‑related activities and reviews associated documentation as required. Creates, reviews, and maintains Quality System Documents, Product Documents, and documents required for the Design History File (DHF). Develops and executes protocols, validation activities, equipment qualifications, and test methods with guidance, as required. Develops and maintains risk assessments, including Failure Modes and Effects Analysis (FMEA) and/or Fault Tree Analysis (FTA), with guidance as required. Participates in Internal and Supplier Quality System Audits and owns assigned audit‑related actions through completion. Supports Design Transfer activities, equipment introductions, and manufacturing process improvements. Manages assigned continuous improvement initiatives, quality improvement projects, and associated action plans, and drives activities through completion. Maintains awareness of industry developments through training and quality‑related professional development activities. Maintains compliance with established corporate safety standards, quality system requirements, operating procedures, and applicable site policies. Other Duties as Assigned, Including but Not Limited To General quality control and quality assurance activities. Product and raw material testing and release. Performs other duties as assigned.

Education and/or Experience - Required

Bachelor's degree in a scientific discipline (Engineering, Engineering Technology, Chemical, Biological, or equivalent). Zero (0) to two (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.

Education and/or Experience - Preferred

Experience supporting validation, Corrective and Preventive Action (CAPA), complaint investigation, quality system auditing, or related quality activities. Experience supporting Environmental Monitoring, microbiological testing, or laboratory quality activities. Experience working in a regulated manufacturing environment. Experience with statistical techniques.

Required Qualifications

Proficiency in Microsoft applications including Word, Excel, Visio, presentation software, Minitab, or equivalent software. Familiarity with regulatory and statutory agencies (FDA, Notified Bodies, etc.). Familiarity with Lean and Six Sigma methodologies. Ability to work effectively in a team environment. Demonstrated organizational and time management skills. Ability to manage multiple assignments and priorities. Ability to interpret Regulations, Organizational, Business Unit, and Department procedures. Strong oral and written communication skills in English. Ability to effectively present information in one‑on‑one and group settings to supervisors, management, and other employees. Ability to represent the Company and Business Unit in a professional manner. Proficiency in mathematics. Basic applied statistics knowledge.

Preferred Qualifications

Ability to translate quality requirements into product specifications. Advanced statistics and/or Six Sigma Green Belt certification. American Society for Quality (ASQ) certification.

Physical Demands

Ability to sit, stand, walk, bend, reach, and perform routine office, laboratory, and manufacturing‑related activities. Ability to use standard office equipment, including computers and communication devices. Ability to occasionally lift and carry materials consistent with normal business operations. Ability to work in manufacturing and laboratory environments, as required. Ability to work in areas containing radioactive materials, as applicable.

Work Environment

Work is performed in office, laboratory, and manufacturing environments. Work may be performed in an open‑cubicle office environment. Exposure to manufacturing and laboratory activities may be required. Use of personal protective equipment (PPE) may be required in designated areas. Candidates must be able to work effectively in a team‑oriented, fast‑paced environment. Occasional travel may be required based on business needs.

Disclaimer

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended to be inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA IL - Carol Stream

Additional Locations

Additional Locations Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs.

Benefits may include

Health & Well‑being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs. Retirement & Financial Well‑being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources. Work‑Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs. Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave. Additional details regarding benefits and well‑being programs can be found in Our Commitment to You.

Salary Range Information

$75,800.00 - $121,300.00 USD Annual

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real‑life health benefits for people today, tomorrow and beyond. We make…

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.