Quality Assurance Engineer - Medical Devices, CAPA

Cutera; Brisbane (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

Cutera, based in Brisbane, CA, is seeking a Quality Assurance Engineer to ensure QMS compliance with global standards and to lead CAPA activities for quality system software. You will collaborate with cross-functional teams to investigate complaints, drive root-cause analysis, and implement corrective actions in a fast-paced medical device environment.

The role requires 1–3 years of regulated industry experience, familiarity with 21 CFR Part 820, ISO 13485, and Part 11, plus a strong capacity

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.
• Familiarity with CAPA and customer complaint processes, quality systems, and internal audits.
• Experience with software validation or computerized system validation is preferred.
• Ability to work effectively on cross-functional projects and collaborate with teams across the organization.
• Strong analytical, organizational, planning, and problem-solving skills.

Responsibilities

• Support compliance of the QMS with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and other regulatory requirements.
• Develop, maintain, and improve SOPs, forms, templates, and other quality system documentation.
• Manage customer complaint investigations from intake through closure.
• Support CAPA investigations including root cause analysis and corrective actions.
• Monitor complaint trends to identify CAPA and product/process improvements.
• Maintain electronic CAPA system and participate in CAPA Review Board activities.
• Review CAPA investigations and action plans for completeness and timeliness.
• Monitor corrective and preventive actions with cross-functional teams to ensure effectiveness.
• Support supplier quality activities including supplier qualification and SCARs.
• Assist with supplier audits and corrective actions to closure.
• Validate quality system software per 21 CFR Part 11 and non-product software systems.
• Prepare quality reports and support management reviews.
• Identify opportunities for process improvement and maintain QMS effectiveness.

Skills

CAPA process

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Documentation

Education

Bachelor's degree in Science/Engineering

Tools

PLM systems

ERP systems

Quality management software

Microsoft Office

Job description

Cutera, based in Brisbane, CA, is seeking a Quality Assurance Engineer to ensure QMS compliance with global standards and to lead CAPA activities for quality system software. You will collaborate with cross-functional teams to investigate complaints, drive root-cause analysis, and implement corrective actions in a fast-paced medical device environment.

The role requires 1–3 years of regulated industry experience, familiarity with 21 CFR Part 820, ISO 13485, and Part 11, plus a strong capacity