Senior Quality Engineer - Bioprocess Equipment (Onsite)

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

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.