Quality Engineer III - 45.00/hr.

Kelly; Santa Clara (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Kelly Quality Engineer role focuses on investigating quality issues, CAPAs, and customer complaints, leading cross-functional problem-solving to sustain product quality. You will apply root cause analysis, risk-based decisions, and rigorous documentation to ensure regulatory compliance in manufacturing and supply chain.

Qualifications include a Bachelor's in Engineering and 5–8 years in quality engineering within regulated industries; strong collaboration with Manufacturing, R&D, and Supplier

Qualifications

• Strong knowledge of quality systems, regulatory requirements and investigation processes.
• Proficient in root cause analysis and structured problem-solving methodologies.
• Ability to independently manage multiple complex investigations.
• Strong analytical and data-driven decision-making skills.
• Effective communication and ability to influence cross-functional teams.
• Detail-oriented with strong technical documentation skills.
• 5–8 years of quality engineering experience in regulated industries.
• Experience leading nonconformance investigations, CAPAs, and customer complaints.

Responsibilities

• Investigate quality issues, manage CAPAs and customer complaints.
• Lead cross-functional problem-solving efforts to drive improvements.
• Ensure product quality and regulatory compliance through data-driven actions.

Skills

Root Cause Analysis

CAPA Management

Regulatory Compliance

Cross-functional Collaboration

Data-driven Decisions

Investigation Leadership

Documentation

Troubleshooting

Quality Systems

Education

Bachelor’s degree in Engineering

Job description

Quality Engineer responsible for investigating quality issues, managing CAPAs and customer complaints, leading cross-functional problem-solving efforts, and driving continuous improvement to ensure product quality and regulatory compliance.

• Strong knowledge of quality systems, regulatory requirements, and investigation processes
• Proficient in root cause analysis and structured problem-solving methodologies
• Ability to independently manage multiple complex investigations
• Strong analytical and data-driven decision-making skills
• Effective communication and ability to influence cross-functional teams
• Detail-oriented with strong technical documentation skills
• Bachelor’s degree in Engineering or related technical discipline required.
• 5–8 years of quality engineering experience, preferably in regulated industries (cGMP, ISO 9001/13485).
• Demonstrated experience leading nonconformance investigations, CAPAs, and customer complaint handling.
• Experience working cross-functionally with Manufacturing, R&D, and Supplier Quality.
• Familiarity with failure analysis, and risk-based decision making.