Senior Quality Engineer - CAPA & Root Cause Lead

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

Job summary

Akraya, Inc. is seeking a Senior Quality Engineer in Santa Clara, CA to independently lead complex quality investigations and drive resolution of nonconformances and customer complaints. The role emphasizes regulatory compliance, data-driven improvement, and cross-functional collaboration to strengthen quality processes.

You will guide CAPA activities, perform root cause analysis, and mentor team members while ensuring timely issue resolution in a regulated medical devices context.

Qualifications

• Proven experience leading nonconformance investigations and CAPAs.
• Strong understanding of quality systems and regulatory requirements.
• Proficiency in root cause analysis and structured problem-solving methodologies.
• Experience in regulated industries such as IVD or medical devices with knowledge of ISO 13485 and FDA QSRs.

Responsibilities

• Lead end-to-end CAPA activities, including investigation, root cause analysis, and effectiveness verification.
• Investigate customer complaints, coordinating with teams for failure analysis and root cause determination.
• Serve as a quality lead on cross-functional teams, driving accountability and timely issue resolution.
• Analyze data from nonconformances, CAPAs, and complaints to identify trends and improvement opportunities.
• Provide guidance and mentorship on investigation best practices to team members.

Skills

Root Cause Analysis

CAPA Management

Customer Complaint Handling

Data Analysis

Quality Systems

Job description

Akraya, Inc. is seeking a Senior Quality Engineer in Santa Clara, CA to independently lead complex quality investigations and drive resolution of nonconformances and customer complaints. The role emphasizes regulatory compliance, data-driven improvement, and cross-functional collaboration to strengthen quality processes.

You will guide CAPA activities, perform root cause analysis, and mentor team members while ensuring timely issue resolution in a regulated medical devices context.