Senior Quality Engineer - Development & Devices

Thornton Tomasetti; Menlo Park (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott, located in Menlo Park, CA, seeks a Senior Quality Engineer within the Development Quality team. This role delivers Development Quality support to manufacturing and product development, ensuring the highest quality products reach customers.

Key duties include leading quality improvements, risk analyses, FMEAs, CAPA, and process monitoring, in a cross-functional environment with strong regulatory compliance requirements.

Qualifications

• Bachelor's degree in related area or equivalent experience.
• Minimum 5 years of related work experience.
• Comprehensive knowledge of a technical field and cross-functional dependencies.
• Expert in work group and across functions; quality system environment.

Responsibilities

• Leads product/process improvement by capturing quality metrics and analyses.
• Develops and executes test methods, validation, and design verification.
• Creates quality tools and training materials for teams.
• Develops and implements product quality plans and risk analyses (FMEAs).
• Responsible for risk management and CAPA processes.
• Implements process monitoring systems to reduce variation and defects.
• Works on continuous improvement with cross-functional teams.
• Maintains compliance with regulatory requirements and standards.

Skills

Quality engineering

CAPA

FMEAs

Process Validation

Risk Management

Regulatory compliance

Education

Bachelor's Degree in related area

Master's Degree preferred

Job description

Abbott, located in Menlo Park, CA, seeks a Senior Quality Engineer within the Development Quality team. This role delivers Development Quality support to manufacturing and product development, ensuring the highest quality products reach customers.

Key duties include leading quality improvements, risk analyses, FMEAs, CAPA, and process monitoring, in a cross-functional environment with strong regulatory compliance requirements.