Senior Engineer, Supplier Quality

Requirements

• 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
• Why Join Us?
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers .

Benefits

Additional Information

We are the people who give possibilities purpose 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. Job Description Job Respo nsibilities: 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.

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