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.

BD is seeking a Quality Engineer II to join the team at our medical device manufacturing site in Sumter, SC. As a Quality Engineer II, you'll play an integral role in maintaining compliance with ISO and FDA guidelines while collaborating with local, US-based and international resources. You'll be responsible for building and implementing strategic quality plans and regulatory compliant operating procedures that support routine validation, as well as expansion and upgrade projects. If you're passionate about quality and are looking for a challenging and rewarding career, we want to hear from you!

Responsibilities:

• Serve as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues.

• Maintain familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.

• Provide technical mentorship for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned.

• Ensure the contents of Validation protocols meet all applicable quality system requirements and product requirements.

• Lead projects/project teams in the use of continuous improvement tools and methodologies such as Six Sigma, 8D, 5-Why, etc.

• Work with assigned manufacturing department(s) to maintain the highest quality standards/requirements.

• Initiate, review, and implement policies and procedures relating to product quality and process control as appropriate.

• Ensure that all activities align with government (OSHA, FDA, ISO, etc.) regulations and corresponding policies/procedures.

• Coordinate machine and process capability studies, analyze data, and submit recommendations.

• Coordinate communication between Unit Quality, Unit R&D, and plant personnel on new products, product improvements, and product issues.

• Provide test and statistical support regarding customer complaint issues and make recommendations on actions to be taken to address the issue.

• Lead MWO / PIC initiation, implementation, and follow-through in support of initiatives within the assigned business team.

Qualifications:

• BA/BS Degree (Major: Engineering, Sciences, Mathematics, or equivalent) (Required) Mechanical Engineering Major (Preferred)

• Minimum of BA/BS Degree AND 3 years work experience in Quality Assurance/Manufacturing OR MSc. Degree AND 1 years work experience (Required).

• Solid understanding of statistical/investigative tools such as control limits, SPC, significance studies, P charts, probability studies, 8D, 5-Why etc. (Required)

• Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal direction. (Required)

• Working knowledge of Validations, IQ, OQ, PQ, and DOEs (Preferred)

• Solid understanding of QSRs / ISO13485:2016 (Preferred)

• Six Sigma training (Preferred)

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.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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.

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