Quality Engineering Manager

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. 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 possibilities.

The Manager, Quality Engineering supports the development and implementation of the Quality Management strategy for the WWISD Design Center in collaboration with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction, sustains a compliant QMS, and supports new product development and product maintenance through application of quality engineering principles for medical devices.

• →Bachelor’s degree in Engineering, Science or related discipline. 
• →Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry.
• →Minimum 3 (three) years of direct management experience of QA professional and technical staff. 
• →Extensive knowledge of applicable regulations and standards including 21 CFR 820, ISO 13485, ISO 14971 and ISO 10993. 
• →Strong understanding of design quality assurance.  
• →Manufacturing and project management experience is desirable. 
• →Knowledge of DFSS, Six Sigma Green Belt or Black Belt are desirable.  Excellent communication, technical writing and leadership skills. 
• → Experience in applying Quality Engineering tools, statistics and problem-solving methodologies. 

Design Control  Change Control  Risk Management - ISO 14971 Process Validation, Design Verification & Design Validation  Identification of CTQs  Unit Quality Independent Reviewer During Design Reviews  Handling of Deviations and Non-Conformances  Test Method Validations  Supplier Qualification  Post Market Surveillance and Situation Analysis  CAPA and Root Cause Investigation  Statistical Analysis Strong strategic planning and prioritization skills Ability to lead and influence in a matrixed, global organization.