Quality assurance specialist

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 :

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.

Last updated : 2024-02-28