The Quality Specialist (Complaints) is responsible for managing the day-to-day complaints processing, including receiving, documenting, evaluating and coordinating investigations of pre- and post-market customer complaints associated with products in accordance with U.S. and international regulations. The Quality Specialist (Complaints) is also responsible for tracking and trending customer complaints and periodically reporting on those results. They will coordinate cross-functional teams to ensure timely completion of the complaint workflow, including the investigation, tracking of product returns and closing of reportable and non-reportable product complaints. This position will ensure that all complaints are properly evaluated for device reporting (MDR), EU, Australia and other countries' vigilance reporting, reporting to EU Notified Body and EU Authorized Representatives, Australian Sponsor as well as other jurisdictions as applicable while ensuring adherence to all applicable US and international regulatory requirements.
ESSENTIAL JOB FUNCTIONS (including but not limited to):
- Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations.
- Evaluate event(s) to determine if the event qualifies as a complaint; escalate complaint to appropriate parties as needed.
- Ensure accuracy, completeness and consistency of documentation, follow-up, communication with other departments and timely closures of all complaints.
- Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventive actions (CAPAs).
- Oversee the disposition of non-conforming material and processes.
- Assist complaint investigation and analysis with personnel performing failure analysis to gather root cause determinations.
- Coordinate with cross-functional departments, including but not limited to, customer Service, Regulatory Affairs, Quality, and others, to gather root cause determinations and properly document complaint closure.
- Interface with customers through customer service when necessary to obtain additional information to support complaint investigation and product returned for investigation.
- Ensure that all complaints are properly evaluated for device reporting (MDR), vigilance reporting, reporting to other jurisdictions, and other entities (Notified Body Authorized Representative as applicable.
- Submit MDR and vigilance reports as well as reports to jurisdictions, and other entities (Notified Body Authorized Representative as applicable.
- Maintain all complaint handling procedures and systems and make updates as necessary to ensure ongoing compliance with U.S. and international regulations.
- Work with Quality team to track and trend customer complaints in accordance with quality metrics and periodically report those metrics, including device type, reason for complaint, functionality and timeliness of the complaint handling, as needed.
- Work with Clinical Affairs to support investigation of investigational devices that are part of a pre-market clinical trial.
- Lead Complaint/MDR determination meetings and CRB meetings.
- Review and evaluate documentation for completeness and consistency; obtain additional information as needed to close the complaint file.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies.
- Draft response communications to inquiries from regulators.
- Support internal and external audits (e.g. FDA, ISO, EU MDR, supplier).
- Assist with other Quality and Regulatory Affairs functions as needed, including special projects.
- Perform other duties as assigned.