Job Description Summary

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 Staff Quality Engineer I is accountable for supporting the ongoing maintenance and improvement of product risk files for medical devices. This role is responsible for conducting periodic reviews, assessing the impact of product changes on risk documentation, and ensuring compliance with applicable regulatory requirements.

Key Responsibilities:

• Lead and executeperiodic reviewsof risk management files to ensure accuracy, completeness, and regulatory compliance.

• Evaluate and update risk documentation in response toproduct design changes, manufacturing updates, or post-market feedback.

• Providerisk management support for new product development, including initial hazard analysis, risk file creation, and integration with design control processes.

• Collaborate cross-functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use.

• Maintain alignment withISO 14971risk management principles and ensure documentation meetsIVDR/MDRexpectations.

• Support internal and external audits by providing risk file documentation and responding to auditor inquiries.

• Track and manage risk file updates using document control systems and ensure timely approvals.

• Participate in risk-related training and continuous improvement initiatives.

Required Qualifications:

• Bachelor’s degree in science, engineering, or other relevant discipline and 8 years relevant experience OR
• Master's degree in science, engineering, or other relevant discipline and 5 years relevant experience

Skills:

• Extensive knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. -21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.

• Experience with risk management tools such asFMEA,Fault Tree Analysis, orHazard Analysis.

• Excellent written and verbal communication skills.

• Detail-oriented with strong organizational and analytical skills.

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.

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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.

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