Sr. Supplier Quality Engineer

Becton Dickinson Medical Devices•Milpitas, CA

About The Position

The Sr. Supplier Quality Engineer provides quality guidance and oversight to key suppliers, ensuring alignment with Waters’ quality, regulatory, and industry-standard requirements. The role supports supplier quality controls that meet Waters, FDA, and other applicable regulatory requirements, while identifying quality needs, product improvements, and customer requirements. The position supports new product development and sustaining activities in supplier management, helping ensure supplier compliance and capability for qualification, approval, and ongoing product support. It also ensures design-control documentation and records are maintained throughout the design-history lifecycle. The engineer supports supplier qualification and approval, including supplier selection, quality planning, risk analysis, critical-to-quality characteristics, supplier specifications, DFM reviews, validations, verifications, quality agreements, supplier history files, and related activities. The role may also support Field Corrective Actions, build strong supplier business and quality relationships, and establish initiatives to continuously improve Supplier Quality Management Systems.

Requirements

Bachelor of Science or Bachelor of Arts degree in an engineering or science field.
At least 3 years of Supplier Quality experience in a manufacturing environment operating under FDA- or ISO-regulated 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, including the ability to deliver effective presentations.
Strong background in manufacturing processes, including process development and optimization.
Experience managing a variety of commodities, such as instrument finished goods, optics/lasers, contract manufacturers, PCBAs/electronics, sheet metal, machined parts, cabling harnesses, chemistry, or biological products.
Proficiency in project management, analytical thinking, critical thinking, problem solving, and prioritization.
Ability to demonstrate innovation and implementation skills.
Knowledge of statistics and data analysis to drive data-based results and decisions.
ISO 9001/13485 lead auditing experience.
Strong problem-solving skills at both the process and product levels.
Ability to travel 20%.

Nice To Haves

Six Sigma Green Belt and/or a quality-engineering certification (e.g., ASQ), or equivalent; Six Sigma Black Belt certification is preferred.
Experience with SAP, Minitab, and quality systems software such as TrackWise.

Responsibilities

Provide guidance and quality oversight for key suppliers to ensure alignment with Waters quality, regulatory, and industry-standard requirements.
Ensure controls meet Waters, 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 the design-history lifecycle.
Support supplier qualification and approval, including supplier selection, quality planning, risk analysis, critical-to-quality characteristics, supplier specifications, DFM reviews, validations, verifications, quality agreements, and supplier history files.
Support Field Corrective Action activities when needed.
Partner with suppliers to develop strong business and quality relationships through effective communication and collaboration.
Establish initiatives to support ongoing improvement of Supplier Quality Management Systems.
Lead supplier capability assessments.
Travel up to 20%.