About Us: Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business and reap the rewards of doing it! We hire the best people and provide them the best comp and benefits to help improve their lives. Read more at www.cutera.com

Position Summary:

The Complaint Handling Specialist is responsible for coordinating the review, investigation, and corrective actions associated with product complaints in accordance with quality system requirements and applicable regulations.

Perform review and disposition of customer complaints including overseeing technical complaint investigations.

Provide assistance in all areas of complaint handling including supporting adverse event reporting to ensure that the customer complaints are handled in an accurate and timely manner.

Duties and Responsibilities:

• Oversee and maintain customer complaints process at Cutera.
• Responsible for accurate complaint entry for medical devices for both domestic and international customers.
• Liaise with stakeholders from different functions to obtain any additional information required and follow up on any RMA required to complete the technical investigation.
• Review any technical investigations and collaborate with cross-functional teams for approvals.
• Perform final review for closure of non-reportable complaint files to ensure accuracy, completeness, and attention to detail.
• Generate complaint closure notices.
• Support the evaluation of complaints for Medical Device Report (MDR) and Vigilance Report to ensure all necessary records are available.
• Analyze complaints, quality investigations, and adverse events to ensure consistency, attention to detail, and correct issue coding.
• Provide customer complaints data for management.
• Support post market surveillance core team by generate complaint trend reports and evaluate findings for corrective actions.
• Facilitate the transfer of complaints process from paper-based to electronic system.
• Other duties as assigned.

• Bachelor's degree in Science or Engineering or related discipline.
• 2+ years of industry experience, preferably in medical devices.
• Knowledge of applicable international regulations and standards inc. ISO 13485, 21 CFR Part 820 and EU MDR.
• Strong written and verbal communication skills.
• Significant attention to detail and highly organized.
• Ability to work in a fast-paced, team-oriented environment with strict deadlines.
• Proficient in Microsoft suite including Word, Excel, PowerPoint, and statistical analysis tools.

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.