Bdx
Quality Engineer II
USA SC - Sumter · Mid
Sponsorship not specifiedDetected 4 days ago
AuditingFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- The Quality Engineer at Becton, Dickinson and Company will be responsible for ensuring the quality of medical devices and processes throughout their lifecycle.
Responsibilities
- 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.
- 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.
- Support supplier quality management activities, including supplier selection, auditing, and performance monitoring.
- We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture.
Nice to have
- 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.
- Prepare and present quality reports and metrics to management.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 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.
Skills
- Excellent analytical, problem-solving, and communication skills.
Compensation
- 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
Benefits
- 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.
- We welcome people with the imagination and drive to help us reinvent the future of healthcare.
Company info
- Becton, Dickinson, and Company is an Equal Opportunity Employer.
- We are the people who give possibilities purpose
Visa & Work Authorization
- 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 orientatio
This listing is sourced directly from Bdx's careers page and normalized into a canonical job model.