Sr. Quality Engineer

Becton Dickinson Medical Devices • Carol Stream, IL

1d • Onsite

About The Position

This position serves as the primary Quality Assurance (QA) resource responsible for supporting the implementation and ongoing effectiveness of the Quality System. The role performs a wide range of quality-engineering activities and support tasks aligned with business objectives, while developing and applying expertise in 21 CFR 820 and 803, ISO 9001/13485, and EU MDR. Responsibilities include supporting Design Control projects and providing essential support to the Quality System, Document Control, Manufacturing, and Investigations (including CAPA, Complaints, Nonconformance, and Unscheduled Maintenance). This position also provides leadership and facilitation for key Quality Management activities.
We are the makers of possible 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through the application of advanced quality engineering principles and methodologies. This role plays a critical part in maintaining compliance with all relevant regulations and standards throughout the product lifecycle.

Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field).
• 5+ years of experience in Quality Engineering within the medical device industry.
• Strong understanding of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant medical device regulations and standards.
• Proven experience with design controls, risk management (ISO 14971), process validation (IQ, OQ, PQ), and statistical process control (SPC).
• Demonstrated ability to lead root cause analysis investigations and implement effective CAPAs.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to effectively present technical information.

Nice To Haves

• Proficiency in statistical software (e.g., Minitab, JMP) is preferred.
• ASQ certifications (e.g., CQE, CSSBB) are a plus.

Responsibilities

• Develop, implement, and maintain comprehensive quality systems and procedures in accordance with FDA regulations (21 CFR Part 820), ISO 13485, and other applicable global standards.
• Lead and participate in design control activities, including design verification, validation, risk management, and design transfer to manufacturing.
• Conduct root cause analysis for product non-conformances, CAPAs, and customer complaints, implementing effective corrective and preventive actions.
• Develop and execute statistically sound sampling plans and inspection methods for incoming materials, in-process production, and finished goods.
• Perform internal and external quality audits to assess compliance and identify areas for improvement.
• Collaborate with R&D, manufacturing, regulatory affairs, and supply chain teams to ensure quality is built into products from concept through commercialization.
• Review and approve engineering changes, deviations, and non-conformances, ensuring appropriate impact assessment and resolution.
• Generate and analyze quality metrics, trending data, and prepare reports for management review.
• Provide guidance and mentorship to junior quality engineers and other team members on quality-related matters.
• Support regulatory submissions and responses to regulatory inquiries as needed.

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
• Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level