Job Description Summary

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.

Job Description

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. 

Job Summary
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.

Job 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.

Job Qualifications

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

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

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.

Required Skills

Optional Skills

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Primary Work Location

USA IL - Carol Stream

Additional Locations

Work Shift

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. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$92,700.00 - $152,900.00 USD Annual