Quality Assurance Engineer: CAPA & QMS Validation Lead

Cutera, Inc.; Brisbane (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Cutera, Inc. is seeking a Quality Assurance Engineer to ensure the QMS complies with regulations and standards. The role will maintain CAPA, lead software validation, and collaborate across functions to drive quality improvements.

Responsibilities include supporting regulatory requirements, SOP development, and supplier quality activities. The candidate should have a science/engineering background and 1–3 years in a regulated environment.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 1–3 years of experience in a highly regulated medical device or similarly regulated environment.
• Working knowledge of 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11.

Responsibilities

• Maintain and improve the CAPA system and QMS documentation.
• Lead validation activities for quality system software in compliance with 21 CFR Part 11.
• Support supplier quality activities and audits, including CAPA and follow-up actions.
• Prepare quality reports and metrics to monitor performance and trends.
• Support internal and external audits, including FDA and notified body inspections.

Skills

Quality assurance

CAPA

Regulatory compliance

Cross-functional teamwork

Analytical skills

Education

Bachelor’s degree in Science/Engineering

Tools

Microsoft Office

PLM

ERP systems

Job description

Cutera, Inc. is seeking a Quality Assurance Engineer to ensure the QMS complies with regulations and standards. The role will maintain CAPA, lead software validation, and collaborate across functions to drive quality improvements.

Responsibilities include supporting regulatory requirements, SOP development, and supplier quality activities. The candidate should have a science/engineering background and 1–3 years in a regulated environment.