Quality Engineer I
BD
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Benefits offered by this job
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
Education
Tools
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.
- 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.
- General quality control and quality assurance activities.
- Product and raw material testing and release.
- Performs other duties as assigned.
- 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.
- 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.
- 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.
- Ability to translate quality requirements into product specifications.
- Advanced statistics and/or Six Sigma Green Belt certification.
- American Society for Quality (ASQ) certification.
- 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 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.
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.
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.
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USA IL - Carol Stream
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.
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.
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
$75,800.00 - $121,300.00 USD Annual
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