Quality Engineer II

Quality Engineer

The Quality Engineer at Becton, Dickinson and Company will be responsible for ensuring the quality of medical devices and processes throughout their lifecycle. This role involves applying quality assurance principles and practices to design, development, manufacturing, and post-market surveillance activities to maintain compliance with regulatory requirements and internal standards.

Job Responsibilities

• Develop, implement, and maintain quality plans, procedures, and specifications for new and existing products.
• Participate in design control activities including risk assessments (e.g., FMEAs), and validation efforts.
• Lead and support root cause analysis investigations for product and process non-conformances, implementing effective corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs) to ensure quality is integrated and sustained throughout the manufacturing processes.
• Analyze quality data, identify trends, and recommend process improvements to enhance product reliability and reduce defects.
• Review and approve manufacturing documentation, test methods, and validation protocols.
• Support supplier quality management activities, including supplier selection, auditing, and performance monitoring.
• Prepare and present quality reports and metrics to management.

Job Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of experience in a Quality Engineering role within the medical device or pharmaceutical industry.
• Strong understanding of quality system regulations (e.g., ISO 13485, 21 CFR Part 820, EU MDR).
• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, Root Cause Analysis, CAPA).
• Experience with risk management activities.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• ASQ certifications (e.g., CQE, CSSGB) are a plus.

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.

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.

Primary Work Location: USA SC - Sumter

Work Shift: US BD 1st Shift 8am-4:30pm (United States of America)