Senior Design Quality Engineer — NPI & Compliance Lead

MS0062 USA Instruments, Inc; South Dakota; On-site; USD 95,000 - 130,000; Full time

Job summary

GE HealthCare is seeking a Design Quality Engineer to lead quality and regulatory activities for MR Coil projects. You will drive compliance with QMS and standards such as 21CFR820 and ISO13485 across design, transfer, manufacturing, and service while ensuring audit readiness and patient safety.

You will collaborate cross-functionally to enable robust quality decisions, employing CAPA, lean methods, and risk management to support successful product introductions and ongoing quality improvements.

Qualifications

• Bachelor’s degree or 6+ years of relevant experience in QA/Design Controls in a regulated industry.
• 3+ years in Quality Assurance/Quality Engineering in medical devices.
• Knowledge of FDA 21CFR Part 820 and ISO13485.
• Experience with CAPA and root cause investigations.
• Authorized to work in the U.S.; visa sponsorship not available.

Responsibilities

• Lead quality and compliance activities across design, development, transfer, manufacturing, and service for MR Coil technologies.
• Ensure adherence to GE HealthCare QMS and regulatory requirements (21CFR820, ISO13485, MDSAP) while improving processes.
• Represent GE HealthCare to regulatory agencies and drive audit readiness.
• Perform internal audits and oversee CAPA, root cause analyses, and nonconformances.
• Support product launches and design/manufacturing transfers; apply Lean to improve efficiency.

Skills

Quality culture

Regulatory knowledge

CAPA investigations

Design Controls

Lean methodologies

Education

Bachelor's degree

High school diploma + 6 years exp

Job description

GE HealthCare is seeking a Design Quality Engineer to lead quality and regulatory activities for MR Coil projects. You will drive compliance with QMS and standards such as 21CFR820 and ISO13485 across design, transfer, manufacturing, and service while ensuring audit readiness and patient safety.

You will collaborate cross-functionally to enable robust quality decisions, employing CAPA, lean methods, and risk management to support successful product introductions and ongoing quality improvements.