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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.

Responsibilities:

• Consistent application of quality engineering principles (e.g. acceptance sampling, statistical process control, measurement/test methods, quality planning, failure investigation, design of experiments, process FMEA, value stream mapping, hypothesis testing, descriptive statistics, process capability)

• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

• Develops validation protocols based on business and operations needs. Ensure product development and validation programs meet requirements of FDA and ISO when applicable.

• Leads execution of non-conforming material (Quality Notification) process per company procedures, ensuring approaches result in effective control and efficient operations.

• Proven problem solving skills. Leads CAPAs related to area of responsibility.

• Makes measurable improvements to BD processes and procedures

• Evaluates the effectiveness of the established Quality System and Good manufacturing Practices (Auditor-in-Training)

• Lead moderately complex risk management activities including risk management reviews, risk analysis, updating/maintaining process hazard analysis, and presenting to Risk Management board.

• Ensures that all sustaining design change control and production / process control projects meet applicable regulatory (local and international), Corporate, and Segment requirements

Education and/ or Experience Required:

• Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.

• Minimum 8+ years’ experience in quality assurance field in a regulated environment required

• Minimum 4+ years’ experience in medical device industry required

• Working knowledge and experience on at least 2 of these standards required: 21CFR part 820 (QSR), ISO13485, ISO14971, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 62366-1, ISO 10993-1

• Results orientation with strong written and oral communications skills to lead cross-functional teams are required

• Candidate must be able to work autonomously and independently in addition to providing guidance to Junior engineers

• CAPA experience- Candidate to have owned and completed a CAPA successfully

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 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, or any other protected status.

PDN

SWE

Primary Work Location

USA NC - Durham - Roche Drive

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.