Senior Supplier Quality Engineer

Job Description Summary

The Senior Quality Engineer reports to the Supplier Quality Manager and supports the supplier management program at BD Biosciences (BDB) Milpitas unit. The associate will be responsible for supporting the qualification, approval, and sustaining activities for suppliers for BDB Milpitas site and other sites as needed.

• Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, FDA, and other applicable regulatory requirements and identify quality needs, product improvements and customer requirements.
• Drive and support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensure adequate design control documentation and records are maintained to support life cycle of design history.
• Provide quality support for Supplier Qualification and Approval steps and ensure they are completed adequately including supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and design for manufacturability reviews, validations, verifications, quality agreements, supplier history files and other activities as needed.
• Support activities relating to Field Corrective Actions, when needed.
• Facilitate and partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.
• Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems.

• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820.
• Excellent people interaction, team building, leadership, and communication skills including effective presentations.
• Strong background in manufacturing processes including process development and optimization.
• Experience managing a variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses or Chemistry or Biological products.
• Proficient in project management, analytical, critical thinking, problem solving and prioritization skills.
• Demonstrate innovative and implementation skills.
• Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions.
• ISO 9001/13485 lead auditing experience.
• Strong solving skills at both process and product level.
• Experience in SAP, Minitab, and Quality Systems Software (e.g., Trackwise) is a plus.
• Lead Supplier Capability Assessments.

• B.S. or B.A. degree in an engineering or science field.
• Minimum of 3 years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment.
• ASQ certifications desired.

$ - $ USD Annual

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.