Senior Quality Engineer - Manufacturing: 26-02433

Akraya, Inc.; Santa Clara (CA); On-site; USD 55,000 - 62,000; Full time

Job summary

Akraya, Inc. is recruiting for a Quality Engineer to support bioprocessing equipment manufacturing, integration, and testing.

You will ensure quality is built into every phase and work across departments to meet release criteria on time. You will actively resolve production floor quality issues, develop compliant documentation, and lead CAPA investigations while tracking metrics to drive ongoing improvements.

Qualifications

• 4+ years of Quality Engineering experience in a regulated manufacturing environment.
• Experience with Quality Management Systems (Document Control, CAPA, Deviations, etc.).
• Ability to interpret technical documentation and schematics.

Responsibilities

• Ensure quality requirements are met during equipment build, integration, and testing phases.
• Address and resolve real-time quality issues on the production floor.
• Develop and maintain quality system documentation and processes.
• Lead investigations for deviations, nonconformances, and CAPAs.
• Monitor and analyze site quality metrics to drive continuous improvement.

Skills

Quality Engineering

CAPA & Deviations

Document Control

Medical device field

Job description

Contract Type: W2, Duration: 12 Months, Location: Santa Clara, CA 95054, Pay Range: $40/hr - $45/hr

Job Summary: This role focuses on providing critical quality engineering support for the manufacturing, integration, and testing of specialized bioprocessing equipment. You will collaborate with various departments to ensure quality standards are met throughout project lifecycles, from initial build to final release. This position also involves hands-on problem-solving on the production floor and managing quality systems compliance.

• Ensure quality requirements are met during equipment build, integration, and testing phases.
• Address and resolve real-time quality issues on the production floor.
• Develop and maintain quality system documentation and processes.
• Lead investigations for deviations, nonconformances, and CAPAs.
• Monitor and analyze site quality metrics to drive continuous improvement.

Must Have Skills:

• 4+ years of Quality Engineering experience in a regulated manufacturing environment.
• Experience with Quality Management Systems (Document Control, CAPA, Deviations, etc.).
• Ability to interpret technical documentation and schematics.
• Experience in the medical device or biopharmaceutical equipment manufacturing industry is preferred.

Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022).

Industry Leaders in Tech Staffing As Talent solutions provider for Fortune 100 Organizations, Akraya's industry recognitions solidify our leadership position in the IT staffing space.

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