Senior Supplier Quality Engineer - FDA/ISO Expert

Regulatory Jobs; Milpitas (CA); On-site; USD 110,000 - 176,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Parental leave

Commuter benefits

Job summary

Waters Corporation is seeking a Supplier Quality Engineer to oversee key suppliers in a regulated manufacturing environment. You will ensure supplier quality aligns with Waters requirements, manage qualification/approval activities, and maintain design control records throughout product lifecycles.

The role emphasizes collaboration with quality, manufacturing, and regulatory teams; you will drive continuous improvement, participate in risk analyses, and support corrective actions.

Qualifications

• Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820.
• Experience in supplier quality in a manufacturing FDA/ISO regulated environment.
• Six Sigma Green Belt and/or ASQ Quality Engineer (Black Belt preferred).
• Proficient in project management, analytical thinking and data-driven decision making.

Responsibilities

• Provide quality oversight for key suppliers to ensure Waters quality, regulatory and industry requirements.
• Drive supplier qualification and approval activities with design control documentation.
• Support supplier quality plans, risk analysis, and CQV/DFM reviews as needed.
• Lead and support field corrective actions and continuous improvement with suppliers.
• Foster strong, collaborative supplier relationships and performance on quality metrics.
• Travel up to 20% to supplier sites and cross-functional teams.

Skills

People leadership

Communication skills

Project management

Analytical thinking

Problem solving

Statistical analysis

Travel readiness

Education

B.S. or B.A. in engineering or science

Tools

SAP

Minitab

TrackWise

Job description

Waters Corporation is seeking a Supplier Quality Engineer to oversee key suppliers in a regulated manufacturing environment. You will ensure supplier quality aligns with Waters requirements, manage qualification/approval activities, and maintain design control records throughout product lifecycles.

The role emphasizes collaboration with quality, manufacturing, and regulatory teams; you will drive continuous improvement, participate in risk analyses, and support corrective actions.