Quality Engineer

Company Description

Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint.

We design, develop, manufacture, and market medical instruments used in dermatology for advanced energy-based medical aesthetic solutions. Founded in 1998, the corporate headquarters for the Company is located in Brisbane, CA (just outside of San Francisco) and we are proud to manufacture all of our systems and accessories at our headquarters.  Read more at www.cutera.com

Job Description

The Quality Engineer works with a team of dedicated individuals supporting manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The Quality Engineer evaluates product quality issues, performs root cause analysis, identifies remedial actions, and follows up to ensure all actions are completed satisfactorily prior to issue resolution and closure. You will take the lead on developing and implementing manufacturing process improvements with the goal of increasing efficiency, sustainability and quality of processes while maximizing resource utilization and minimizing costs.

The Quality Engineer works cross functionally with Design and Manufacturing Engineering teams, Procurement, Supply Chain, Warehousing and Manufacturing and Quality Technicians. This dynamic role is engaged in monitoring and improving key areas of Cutera's Quality Management System such as incoming inspection, final quality inspection, NCR, MRB, Supplier Quality and CAPA processes.  The Quality Engineer will have an active role in supplier management and supplier quality.

Duties and Responsibilities:

• Develops and validates quality assurance procedures, sampling plans, methods, equipment and processes.
• Monitors manufacturing procedures, processes, and records for compliance with established requirements.
• Evaluates deviations and non-conformances and supports resolution of quality issues.
• Supports process validation and verification.
• Reviews and trends product and process quality issues using data analysis and root cause investigation.
• Responds to quality escalations and provides technical support for troubleshooting, repair, and testing of products and components.
• Performs risk analysis and determines quality dispositions for engineering change orders, deviations and non-conformances.
• Represents the department cross-functionally in meetings that may include senior and external personnel.
• Releases process and document changes through engineering change orders and deviations using following Cutera change control procedures.
• Escalates to direct management all quality issues that could impact product safety and/or product efficacy.
• Ensures successful, on-time completion of department projects, communicates constraints, delays and results to direct management.
• Develop quality plans and strategies for supplier selection, evaluation, and monitoring to ensure compliance with product specifications and quality standards.
• Assesses and qualifies potential suppliers based on their quality systems, manufacturing capabilities, and adherence to procedures and industry standards.
• Collaborates with suppliers to resolve quality issues, improve process capabilities, and enhance product quality.
• Provides guidance and support to help suppliers meet quality requirements.
• Establishes metrics and key performance indicators (KPIs) to track and measure quality team performance and supplier performance.
• Regularly reviews performance data and take appropriate actions to address any deviations or non-conformities.
• Leads and participates in the investigation of quality issues, non-conformances, and customer complaints. Develops and implements corrective and preventive actions to address root causes and prevent recurrence of quality issues.
• Drives continuous improvement initiatives at Cutera HQ and with suppliers to enhance product quality, reduce defects, and increase quality of products and processes.
• Maintains accurate records of supplier evaluations, audits, performance data, and quality-related documentation. Prepares and presents reports on supplier quality performance to management.
• Assist in the implementation of new technologies, tools, and systems to improve process efficiency and defect prevention.
• Drafts process flow charts, work instructions, quality alerts, and analysis reports.
• Develops data collection plans including test results analysis.
• Leads cross functional problem analysis and resolution efforts.
• Ensures that applicable regulatory and internal policies are followed.

Qualifications

Requirements: