Quality Engineering Manager
Becton Dickinson · San Diego Bldg A&B, CA
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Role summary
Becton Dickinson seeks a Quality Engineering Manager to lead quality systems development and implementation at their San Diego Design Center. The role oversees a team of quality engineers, ensures regulatory compliance with FDA and ISO standards, and drives quality strategy for medical device development and maintenance.
What they're looking for
- Bachelor's degree in Engineering, Science, or related discipline
- Minimum 10 years progressive quality assurance experience in FDA-regulated industry
- Minimum 3 years direct management experience of QA professionals and technical staff
- Extensive knowledge of 21 CFR 820, ISO 13485, ISO 14971, and ISO 10993
- Strong design quality assurance understanding and design control expertise
- Experience with quality engineering tools, statistical analysis, and problem-solving methodologies
- Excellent communication, technical writing, and leadership skills in matrixed organizations
What you'll be doing
- Lead development, sustenance, and continuous improvement of compliant quality management systems
- Execute and report progress of quality strategic initiatives and regulatory compliance efforts
- Manage team of Quality Engineers and provide leadership for multidisciplinary projects
- Provide quality engineering support, promote statistical tools in design activities, and lead risk management activities
- Develop technical solutions to complex quality problems and drive continuous improvement
Privacy & handoff
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