Please note that this is a 7 months contract position.
•Take ownership for the timeliness and thoroughness of complaint files.
•Triage and evaluate product quality complaints and process product quality complaints.
•Review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed.
•Classify complaints for Medical Device reportability (MDRs) and potentially Vigilance reportability (i.e. MDV) as required.
•Perform follow-up activities to gain additional information as needed.
•Manage and track communication with customers, hospitals, sales representatives, etc.
•Assist with developing training presentations for the complaint handling database and
systems. Deliver training to colleagues and partners as necessary.
•Create reports extracting complaint data out of the complaint handling database.
•Monitor complaint records to ensure standard process is being followed and complaints are closed as required.
•Create customer response letters upon request.
•Support internal and external audits/inspections.
•Support quality and compliance investigations (CAPA or NC) as required.
•Perform overall complaint review and closure activities.
•A minimum of a Bachelor’s degree is required; a concentration in a scientific, healthcare or other technical discipline is required.
•A minimum of 4 years of experience in a GMP/ISO regulated environment is required.
•Experience working in a quality system framework (ISO 9001 or similar) is required.
•Medical device, diagnostic and/or pharmaceutical industry experience is required.
•Proficiency with Microsoft Office applications, Adobe Acrobat, and ability to quickly and efficiently extract data is required.
•Experience with MDRs and/or MDV’s is an asset.
•Experience with failure analysis and root cause determination is preferred.
•Project management and/or project leadership abilities are an asset.
•Working knowledge of quality system requirements (QSR), ISO 13485 and Risk Management ISO 14971 is preferred.
•Experience with Failure Mode Effects and Analysis is preferred.
•Experience or understanding of Neurovascular products and clinical procedures related•Experience or understanding of Ear, Nose, and Throat (ENT) balloon sinuplasty products and clinical procedures related •Experience with procedure change order processing•Strong Quality-minded writing
For consideration, please reference job number 2721