Becton Dickinson seeks a Quality Engineer II to lead quality assurance, document control, and design control processes for a product line. The role involves cross-functional collaboration with manufacturing, R&D, and product development teams to ensure regulatory compliance and drive quality improvements.
Responsibilities
- Lead design control and quality assurance on cross-functional product development and process improvement projects
- Develop, review, and approve quality documentation including CAPAs, DHFs, validation protocols, and risk analyses
- Investigate nonconformances and lead corrective and preventive actions for sustainable improvements
- Conduct internal and supplier audits, review customer complaints, and chair design review activities
- Monitor and trend quality metrics to identify and drive continuous improvement opportunities
Requirements
- Bachelor's degree in Biomedical or Electrical Engineering
- 2+ years quality engineering experience in regulated environment
- FDA, MDSAP, PMDA, and CFDA regulatory knowledge
- Statistical analysis and applied methodologies expertise
- Experience managing international suppliers and manufacturers
- Ability to travel internationally up to 15%
Quality Engineer II in covington at Unknown Company
This position is listed as full time and onsite.