Quality Assurance Complaint Specialist

Company Description

Cutera was founded in 1998 by veteran laser and optical engineers who envisioned that technology should and could do more. We have since grown into a global leader of dermatology and aesthetics devices that appeal to forward-thinking clinicians who seek the next generation of performance, safety, and efficacy.

Job Description

Job Description:

The Quality Assurance Complaint Specialist works with a team of dedicated individuals supporting manufacturing, service, engineering, reliability, clinical, and quality operations to ensure timely documentation, investigation, resolution trending and reporting of complaints related to Cutera medical devices and device accessories. This role involves collaboration with cross-functional teams to ensure compliance with regulatory requirements and timely resolution of complaints to maintain product quality and customer satisfaction.

Duties and Responsibilities:

• Receive and triage complaints related to medical devices from customers, healthcare professionals, literature, social media and/or regulatory agencies.
• Document complaint details accurately and comprehensively following established procedures.
• Initiate and lead investigations into reported complaints, collaborating with relevant departments such as Quality Assurance, Regulatory Affairs, Engineering, and Manufacturing.
• Evaluate complaint trends and perform root cause analysis to identify potential issues or product deficiencies.
• Develop and implement corrective and preventive actions (CAPAs) to address identified issues and prevent recurrence.
• Communicate with customers, regulatory agencies, and other stakeholders regarding complaint investigations, findings, and resolution.
• Ensure compliance with applicable regulatory requirements, including FDA regulations, ISO standards, and other relevant guidelines.
• Participate in internal and external audits related to complaint handling processes and procedures.
• Provide support for post-market surveillance activities, including adverse event reporting and trend analysis.
• Collaborate with cross-functional teams to continuously improve complaint handling processes and enhance product quality.
• Other duties as assigned.

Qualifications

Qualifications & Requirements:

• Bachelor's degree in a scientific or engineering field, or equivalent experience in the medical device industry.
• Previous experience in complaint handling or quality assurance within the medical device, in vitro diagnostic or pharmaceutical industry preferred.
• Knowledge of FDA regulations, ISO standards (e.g., ISO 13485), and other relevant quality and regulatory requirements.
• Strong analytical and problem-solving skills, with the ability to conduct thorough investigations and root cause analyses.
• Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
• Detail-oriented with a commitment to accuracy and compliance.
• Ability to work independently as well as collaboratively in a team environment.
• Proficiency with complaint handling procedures including but not limited to using complaint management systems and other applicable software applications.

Additional Information

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: $95K to $120K

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 exemplary experience or higher education.

Hybrid work schedule can be accommodated. 

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 Empl