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. 

The incumbent will assure safe and effective products are designed in accordance to FDA and BD requirements. Responsible for leading a team of profession Risk Management focused quality engineers and scientists in developing and maintaining Risk Management processes and documentation for BD Dispensing products and services. Provide design quality, risk management, and reliability expertise to peers, external regulators and notified bodies. Ensure compliance with BD quality systems, policies, procedures and practices and all local, state, federal and BD safety regulations, policies and procedures.

Responsibilities:

• Supervise quality team associates and systems supporting design and development activities and the sub-specialty of risk management.

• Define and continuously improve systems and procedures associated with risk management, risk review, and risk remediation

• Maintain comprehensive knowledge of the products to evaluate the cause and effect of risk.  Facilitate cross-functional exchanges of knowledge and expertise

• Partner with leadership team and corporate representatives to establish and achieve annual metrics

• Lead the Human Factors Evaluation and Reporting activities.

• Lead the assembly of the Safety Assurance Case process and outputs

• Conduct and/or support the execution of internal audits and serve as a SME for external audits and inspections

• Assure that QMS requirements are followed and executed consistently.

• Lead and develop associates to ensure compliance and escalate quality issues to senior management as necessary

• Other tasks as assigned

Qualifications

Education & Experience:

• Bachelor's degree in Quality Assurance, Mathematics/Statistics or Science related field required

• Minimum 5 years of quality process/system experience in manufacturing with cGMP, medical device and ISO regulations

• Minimum 2 years of people leadership and management experience.

• Experienced in risk management techniques and processes

Advanced skills required in:

• Risk Management

• Risk Analysis

• Leadership

• Communication 

Proficient skills required in:

• Quality Systems Knowledge (cGMP’s and ISO)

• Project management

• Problem solving

• Six Sigma

• Team building

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of