Manager, Quality Assurance

Position Overview

This position is accountable for overseeing activities that ensure adherence to Cutera’s Quality Management System (QMS) and maintaining regulatory approvals necessary for marketing medical devices. The role includes evaluating device modifications for quality and regulatory impact and devising strategies for documentation submissions and upkeep within regulatory frameworks efficiently.

Key Responsibilities

• Oversee and sustain the compliance of Cutera's Quality System with global regulatory and client requirements.
• Lead the Quality Assurance department, guiding staff to meet corporate objectives and fostering professional development.
• Promote a company-wide culture of continuous quality improvement across all departments.
• Ensure the organization is audit-ready for regulatory bodies such as the FDA, ISO, and others.
• Manage compliance processes, including CAPA, internal audits, material review boards, and supplier quality activities; design and execute process enhancements.
• Develop, document, and track quality metrics and ongoing objectives continuously.
• Act as Lead Auditor, manage internal audit programs, and resolve any non-conformities from audits.
• Supervise calibration and testing protocols.
• Contribute to new product design and development by conducting risk assessments and quality planning to facilitate production transitions.
• Participate in supplier qualification and monitoring, including conducting supplier audits.
• Educate manufacturing staff on quality system standards, safety, and handling hazardous materials.
• Maintain alignment with FDA, GMP/QSR standards, manufacturing processes, and ISO 13485 requirements.
• Carry out additional responsibilities as assigned.

Qualifications

• Master's or Bachelor’s degree in a technical discipline or equivalent professional experience with over 5 years in Quality System Management, preferably within ISO-certified medical or electronic device companies.
• In-depth familiarity with ISO 13485 regulatory compliance.
• Experience in quality planning, project oversight, verification, validation, and process validation activities.
• Excellent organizational capabilities with a commitment to high-quality standards.
• Leadership skills with hands-on experience managing teams and cross-functional projects collaboratively.
• Ability to connect operational duties with broader business goals, managing several projects simultaneously.
• Proficiency in MS Word, Excel, PowerPoint, and other relevant technical tools for Quality Management and Product Lifecycle Management.
• Strong written communication and documentation skills.
• Ability to operate effectively under pressure while managing deadlines and multiple projects.
• Capability to produce detailed reports for senior leadership and quarterly updates for the Board of Directors.
• Competency in interpreting and applying regulations, standards, and procedures.
• Effective leadership, analytical thinking, and interpersonal communication skills.