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

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.

Requirements:

• BS or MS in Engineering or Physics, or equivalent experience.
• 0-3+ years of experience working in a highly regulated medical device environment.
• Knowledge of Incoming Quality Control process.
• Experience in supplier quality management, supplier development, or a similar role within a manufacturing or engineering environment, preferably in medical devices.
• Proficient in conducting supplier audits and utilizing quality tools, such as root cause analysis, statistical process control (SPC), and failure mode and effects analysis (FMEA).
• Thorough understanding of Geometric Dimensioning & Tolerancing.
• Experience with Metrology, CMM, Laser, or Optical Measurement systems.
• Ability to understand technical drawings.
• Ability to manage multiple tasks in a fast-paced, deadline-driven environment.
• Effective interpersonal, organizational, written, and verbal communication skills.
• Ability to travel domestically and internationally for supplier visits.
• Working knowledge of applicable medical device regulations such as 21 CFR 820, ISO 13485:2016, ISO 14971:2019, EU MDR and MDSAP.
• Experience with IEC 60601-1, IEC 62304, and IEC 62366 requirements.

Preferred skills:

• Auditing training & experience preferred (not mandatory)
• ASQ-CQE, LSS-BB certification or equivalent a plus.

Cutera expects to reasonably pay in the range listed below for this position based on the city and state listed in the job posting:

 Annual base salary: $90,000 - $110,000 

The actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, education, and candidate residence if the position is remote or field-based. We reserve the option to pay above this range for the exemplary experience or higher education. 

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.