Be a trusted partner by leading the selection, assessment, and qualification of suppliers for NPD projects including supplier audits to ensure that products received from external suppliers conform to pre-established requirements
Drive excellence by defining supplier qualification requirements for components, devices and custom materials for NPD projects to ensure the needs from R&D and Manufacturability are balanced
Lead the development, validation, and implementation of inspection and test methods to ensure product quality and compliance with regulatory and internal requirements.
Foster collaboration with BD plants to establish an optimized receiving inspection strategy while promoting inspection at source.
Lead the efforts to ensure optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Build supplier capability and innovation through BD’s supplier excellence initiatives. Identify and implement improvements in products and processes at the suppliers.
Build strong supplier relationships through onsite visits, BD’s supplier relationship management programs, supplier forums and other interactions.
Train, coach, and guide lower-level employees on more complex procedures
Required Education & Qualifications:
Bachelor’s degree in Engineering or Scientific field with 4 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions; OR a Master’s degree in Engineering or Scientific field with 3 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions.
Preferred Qualifications:
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
Demonstrated experience driving component testing, test method validations, and testing equipment
Experience with CAPAs, NCRs, Change Notifications, and/or Auditing
Utilizing design tools such as SolidWorks (or other similar design tools)
Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices is preferred.
Ability to work independently without close supervision.
In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
Demonstrated ability to apply basic statistical quality engineering tools in a manufacturing environment such as Gage R&Rs, control charting, or statistical process controls
Certified Lead Auditor / ASQ Certified Biomedical Auditor
Six Sigma Green or Black Belt Certified
Domestic and International Travel upwards of 25%
Additional Skills:
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Strong problem-solving, organizational, analytical and critical thinking skills
Good leadership skills and ability to influence change
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
