Senior Supplier Quality Engineer - On-site, High-Impact QA

Becton, Dickinson and Company; Milpitas (CA); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Health & dental benefits

401(k) plan

Paid time off

Education assistance

Job summary

Waters seeks a Senior Supplier Quality Engineer to oversee supplier quality programs in a regulated manufacturing setting. You will drive supplier qualification, quality planning, risk analysis and collaboration across teams to ensure compliant, capable suppliers.

The role requires strong data analysis, communication skills, and experience with FDA/ISO requirements. On-site work in Milpitas with competitive compensation and benefits.

Qualifications

• Minimum 3 years of supplier quality experience in a manufacturing FDA or ISO regulated environment.
• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs (CFR 820).
• ISO 9001/13485 lead auditing experience is a plus.
• Experience with SAP, Minitab and Quality Systems Software (e.g., TrackWise).

Responsibilities

• Provide guidance and quality oversight for key suppliers to meet Waters Quality, Regulatory and Industry standards.
• Ensure supplier controls meet FDA, regulatory requirements and support product improvements and customer needs.
• Lead supplier qualification and approval activities including quality planning, risk analysis, QT/QC reviews and supplier history files.

Skills

Supplier Quality

Six Sigma Green Belt

Project management

Regulatory compliance

Data analysis

Education

Bachelor’s degree in engineering or science

Tools

SAP

Minitab

TrackWise

Job description

Waters seeks a Senior Supplier Quality Engineer to oversee supplier quality programs in a regulated manufacturing setting. You will drive supplier qualification, quality planning, risk analysis and collaboration across teams to ensure compliant, capable suppliers.

The role requires strong data analysis, communication skills, and experience with FDA/ISO requirements. On-site work in Milpitas with competitive compensation and benefits.