Senior Quality Manager
Becton Dickinson & Co
Waters seeks a Senior Quality Manager to lead quality systems and engineering for micro reagents manufacturing in Maryland. The role ensures FDA, ISO 13485, and MDSAP compliance while driving continuous improvement, audit readiness, and quality management effectiveness. This position partners with cross-functional leaders to establish quality strategies and maintain operational excellence.
Responsibilities
- Lead Quality Systems and Quality Engineering activities for Micro Reagents manufacturing operations
- Develop and maintain QMS procedures ensuring FDA, ISO 13485, and MDSAP compliance
- Lead internal, external, and regulatory audits; manage CAPA processes and resolution
- Establish quality objectives aligned with business priorities and drive improvement programs
- Lead, coach, and develop Quality Engineering managers and professionals
Requirements
- Bachelor's degree in Engineering, Science, Quality, or related technical discipline
- 6-8 years progressive leadership experience in Quality Engineering or regulated industry
- Experience managing Quality Management Systems in manufacturing environments
- Experience leading quality teams and driving objectives through influence
- Knowledge of FDA QMSR, ISO 13485:2016, and MDSAP regulatory requirements
- Demonstrated ability to manage departmental budgets and performance metrics
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