Quality Improvement Engineer – CAPA & NC Lead

Intuitive; Peachtree Corners (GA); On-site; USD 127,000 - 183,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Continuous Improvement Quality Engineer (CIQE) to enhance quality systems and manufacturing processes on-site in the U.S.

The role focuses on CAPA/NC activities, regulatory compliance, and cross-functional collaboration to improve product quality and patient outcomes. The position requires a bachelor’s in engineering with 4+ years in regulated industries, plus strong problem-solving and data-analysis skills.

Qualifications

• Quality Engineer with systems, assurance, or QC background and 4+ years of experience.
• Experience in regulated manufacturing industries (medical devices, pharma, etc.).
• NC/CAPA experience and use of quality tools and methodologies.
• Knowledge of 21 CFR 820 and ISO 13485 (3+ years).
• Ability to operate in a matrixed, global environment with attention to detail.
• Strong problem-solving, data collection, and trend analysis skills.

Responsibilities

• Ensure quality systems, products, and processes meet ISO 13485 and 21 CFR820.
• Drive NC/CAPA actions and track timely closure with robust investigations.
• Collaborate with subject matter experts across functions on improvements.
• Lead and participate in NC/CAPA projects ensuring compliance and records.
• Mentor teams and provide QM training support and documentation oversight.
• Communicate quality issues up to management and escalate when needed.
• Support audits and inspections with SME guidance and evidence.
• Contribute to metrics reporting in accordance with procedures.

Skills

Quality Systems

CAPA

Root Cause Analysis

Six Sigma

cGMP

Data Analysis

Communication Skills

MS Office

Education

Engineering Bachelor’s degree

Job description

Intuitive Surgical, Inc. is seeking a Continuous Improvement Quality Engineer (CIQE) to enhance quality systems and manufacturing processes on-site in the U.S.

The role focuses on CAPA/NC activities, regulatory compliance, and cross-functional collaboration to improve product quality and patient outcomes. The position requires a bachelor’s in engineering with 4+ years in regulated industries, plus strong problem-solving and data-analysis skills.