Sr Customer Quality Specialist

at  Advanced Sterilization Products

This position is responsible enhancing customer satisfaction for all customers of Advanced Sterilization Products. The responsibilities include support of the global complaint handling process through completion of reportability determinations, medical reviews, and justifications as well as timely evaluation, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. The role requires approval of complaint investigations, MedWatch Reports, and advancing trends and product problems.

Under general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required.
Independently Completes High Complexity Complaint Investigations within Required Timelines (e.g. Complaints involving Biological Indicators and Chemical Consumables).
Performs visual or functional testing of returned product as required.
Initiates Issue Escalation Process as Required.
Investigates and Documents Complaint Trend Analyses.
Initiates and investigates through Company CAPA and Non-Conformance Processes as Required.
Coordinates and Contributes to Customer Response Letters.
Reviews and Approves Investigations.
Trains More Junior Associates in Company Complaint Handling Processes.
Coordinates Efforts with ASP Legal Department for Complaints Regarding Litigation.
Independently Completes Reportability Determination for US Medical Device Reports (MDRs).
Completes Medical Device Reports (MDRs) to align with Government Reporting Requirements.
Provides Input on MDR Guidelines for Reportability.
Coordinates Medical Reviews and Justifications.
Coordinates Improvement Initiatives.
Coordinates and Contributes to Document Change Orders.
Completes Detailed Gap Assessments to Internal Standards.
Supports Internal Audits of Complaint Handling Department.
Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.
Responsible for communicating business related issues or opportunities to next management level.
Performs other duties assigned as needed.