Quality Engineer II: CAPA, Risk & GMP Specialist

Akraya, Inc.; Fremont (CA); On-site; USD 48,000 - 55,000; Full time

Benefits offered by this job

Job summary

Akraya, Inc. in Fremont, CA is seeking a Quality Engineer for a 6-month, onsite contract to investigate quality issues, drive corrective actions, and ensure compliance with established quality systems in a highly regulated environment.

You will lead CAPAs, perform product and process risk assessments, support new product introductions and change control, and analyze quality data to identify trends and drive improvements.

Qualifications

• Experience in regulated industries (medical devices, pharmaceuticals).
• Proficiency in structured problem-solving methodologies.
• Strong understanding of Quality Management Systems.

Responsibilities

• Investigate and resolve product and process quality issues.
• Lead and execute corrective and preventive actions (CAPAs).
• Conduct and update product and process risk assessments.
• Support new product introductions and change control processes.
• Analyze quality data to identify trends and drive improvements.

Skills

Root Cause Analysis

CAPA Management

Risk Assessment

GMP Compliance

FMEA

Job description

Akraya, Inc. in Fremont, CA is seeking a Quality Engineer for a 6-month, onsite contract to investigate quality issues, drive corrective actions, and ensure compliance with established quality systems in a highly regulated environment.

You will lead CAPAs, perform product and process risk assessments, support new product introductions and change control, and analyze quality data to identify trends and drive improvements.