Quality Engineer II : 26-02883

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

Primary Skills:Root Cause Analysis (advanced), CAPA Management (advanced), Risk Assessment (advanced), GMP Compliance (advanced), FMEA (advanced)

Contract Type: W2 Duration: 6 Months Location: Fremont, CA - 94538 (#LI - Onsite) Pay Range: $35/hr - $40/hr #LP

Job Summary:This role is crucial for maintaining product and process integrity within a regulated environment. You will investigate quality issues, drive corrective actions, and ensure compliance with established quality systems. The position requires a proactive approach to identifying and mitigating risks throughout the product lifecycle.

Key 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.

Must-Have Skills

• Experience with regulated industries (e.g., medical devices, pharmaceuticals).
• Proficiency in structured problem-solving methodologies.
• Strong understanding of Quality Management Systems.
• This role requires experience in a highly regulated manufacturing environment, such as medical devices, in vitro diagnostics, or pharmaceuticals, to ensure adherence to stringent quality and compliance standards.