Senior Supplier Quality Engineer
Posted 1 month ago Expired
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Upload Your ResumeAbout This Role
This role supports the supplier management program at BD Biosciences (BDB) Milpitas unit, ensuring suppliers align with quality, regulatory, and industry standards. The Senior Quality Engineer will also drive new product development and sustaining activities related to supplier compliance and capability.
Responsibilities
- Provide guidance and quality oversight for key suppliers to ensure alignment 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 including supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, and supplier history files
- Support activities relating to Field Corrective Actions
- 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
Requirements
- 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
- Strong background in Manufacturing processes including process development and optimization
- Experience in managing 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
- 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
- Ability to Lead Supplier Capability Assessments
Qualifications
- 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
Nice to Have
- ASQ certifications desired
- Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise)
Skills
* Required skills
Benefits
About BD Nogales Norte
BD is one of the largest global medical technology companies in the world, advancing the world of health through design, engineering, manufacturing, and marketing of MedTech products.