In the role of Sr. Customer Quality Specialist, this individual will:
•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. •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. Qualifications •A minimum of a Bachelor’s degree is required •experience in a GMP/ISO regulated environment •Experience working in a quality system framework (ISO 9001 or similar) is required. •Proficiency with Microsoft Office applications, Adobe Acrobat, and ability to quickly and efficiently extract data is required. •Experience with failure analysis and root cause determination is preferred. •Project management and/or project leadership abilities are an asset. •Experience with Failure Mode Effects and Analysis is preferred. •This position will be based in Irvine, CA and may require up to 10% domestic and international travel.