Design Quality Engineer - CAPA, Risk & Change Lead

Intellectt Inc; Carlsbad (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Intellectt Inc. is seeking a candidate for critical design quality initiatives in Carlsbad, California. This role entails leading design change assessments and supporting risk management documentation for an electromechanical product line.

The ideal candidate will have strong analytical skills, experience managing CAPAs, and expertise in design validation activities, contributing to ongoing product improvements.

Qualifications

• Strong analytical skills necessary for problem solving.
• Experience in a regulated (medical device) environment required.

Responsibilities

• Manage change orders and investigate product issues.
• Support corrective and preventive actions (CAPAs).
• Contribute to design validation activities tied to product improvements.

Skills

CAPA ownership

Root cause analysis

Design change assessments

Risk management documentation

Electromechanical product experience

Job description

Intellectt Inc. is seeking a candidate for critical design quality initiatives in Carlsbad, California. This role entails leading design change assessments and supporting risk management documentation for an electromechanical product line.

The ideal candidate will have strong analytical skills, experience managing CAPAs, and expertise in design validation activities, contributing to ongoing product improvements.