About the role
Job Summary
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.