Manager, Quality Assurance

About the Role

The individual is responsible for activities that lead to and maintain compliance with Cutera’s Quality Management System and regulatory approval to market devices. Additionally, the individual assesses device changes for quality and regulatory implications and develops strategies for submissions and maintenance of documentation within the framework of regulatory requirements.

Responsibilities

• Manage and maintain Cutera’s Quality System to ensure continued compliance with global regulatory and customer requirements.
• Lead and manage Cutera’s Quality Assurance department and employees to achieve organizational goals, employee development, and growth.
• Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments.
• Prepare and maintain organizational readiness for FDA, ISO, and other agency audits of our quality system.
• Lead and manage compliance processes (CAPA, Internal Audit, Material Review Board, Supplier Quality) and implement improvements.
• Formulate, document, and maintain quality metrics and ongoing objectives.
• Serve as a Lead Auditor, develop and manage internal audit systems, and address non-conformities from internal and external audits.
• Oversee calibration and testing systems.
• Participate and provide input into the design and development of new products, including risk analysis and quality planning to transition new products to production.
• Participate in supplier qualification and oversight, including performing supplier audits.
• Train and support manufacturing personnel on quality system requirements, safety, and hazardous material handling processes.
• Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions, and ISO 13485.
• Other duties as assigned.

Requirements

• Master's or Bachelor's degree in a technical field, or equivalent experience with a minimum of 5+ years of experience with Quality System Management for an ISO-certified Technology Company (medical device or electronics devices preferred).
• Extensive knowledge of ISO 13485 compliance.
• Experience in quality planning, project management, verification, validation, and process validation.
• Strong organizational skills and high-quality standards.
• Hands-on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
• Ability to link functional responsibilities to overall business goals and to manage and prioritize multiple projects simultaneously.
• Proficient in the use of MS Word, Excel, PowerPoint, and other technical tools for QMS/PLM management.
• Strong writing and formatting skills.
• Ability to work well under pressure while managing multiple projects and meeting deadlines.
• Provide detailed reports to Senior Management on critical projects as well as quarterly updates to the Board of Directors.
• Ability to read and understand regulations, standards, and procedures.
• Good leadership, analytical, and interpersonal skills.