Senior Engineer Supplier QA

Title: Senior Engineer, Supplier QALocation: Santo Domingo EsteTerm: Temporary (11 months - 1 year)

Job Responsibilities: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 requirementsDrive 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 balancedLead 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 procedure
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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 function
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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 equipmentExperience with CAPAs, NCRs, Change Notifications, and/or AuditingUtilizing 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 controlsCertified Lead Auditor / ASQ Certified Biomedical AuditorSix Sigma Green or Black Belt CertifiedDomestic and International Travel upwards of
25%