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Job Description Summary

The purpose of this position is to manage the design quality aspects of the assigned product lines. This includes assisting other Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Senior Quality Engineer functions as a subject-matter resource for interfacing with cross functional partners in Engineering, Operations, Sterilization, and outside suppliers.

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.

DUTIES AND RESPONSIBILITIES:

• Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.

• Provides Quality Assurance leadership for Project Teams or Quality Department.

• Builds, reviews and approves Quality System Documents (CAPA, Audits)

• Crafts, reviews and approves Product Documents, such as Design History Files

• Creates, reviews, and approves Protocols, Process and Product Validations, Stability Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.

• Protocols, Software Validation documents

• Mentors staff

• Provides supervision to technicians and engineers

• Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.

• Performs Internal or Supplier Quality System Audits.

• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.

• Performs Complaint review and investigation as the need arises.

• Tracks and trends Quality Indicators.

• Collaborate with manufacturing facility or other Division Facilities.

• Serves as Independent QA Reviewer and Chairperson for Design Reviews.

Key Skills and Experience:

• Ability to work independently

• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA

• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability

• Demonstrated history of successfully interpreting regulations, and procedures

• Demonstrated skill in statistical analysis and applied statistical methodologies

• Knowledge and understanding of IEC 60601 standards

Basic Requirements:

• BS/MS Engineering (EE or ME)

• Capital system experience (Electro-mechanical)

• 5 years of experience in FDA regulated environment, with 3 years of product design experience

• 2 years of Quality Engineering experience in a regulated environment

• ASQ Certification

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

Primary Work Location

USA GA - Covington BMD

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.