Quality Engineer II

We are the people who give possibilities purpose

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.
Job Description

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).
• Proven 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)
• Proven understanding of QSRs / ISO13485:2016 (Preferred)
• Six Sigma training (Preferred)

Why Join Us?

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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.


We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.


To learn more about BD visit

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.

Required Skills

Optional Skills

Primary Work Location
USA SC - Sumter

Additional Locations

Work Shift
US BD 1st Shift 8am-5pm (United States of America)