Responsible for the complaint handling process. Coordinate complaint-related activities across multiple functions and sites. Provide complaint handling and quality engineering expertise and consultation to significant / complex projects.
Lead Review Committee meetings for confirmed product failures. Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions). Ensure prompt escalation and complete documentation of product safety.
Ensure documentation and records are complete and in compliance with regulatory requirements. Participate and support internal, external audits and inspections. Ensure Post Market Surveillance activities are completed.
Minimum BA/BS degree in science or other technical field. Experience in the medical device industry. Experience participating in internal and external inspections (e.g., FDA, LRQA).
Knowledge on CAPA, complaint investigation, and field action processes.
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations