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Job Title: Sr. Customer Quality Specialist:
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Pharmaceutical, is recruiting a Customer Quality Specialist, CSS Customer Quality, to be located in Irvine, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, Sterilmed, and Cerenovus. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Reprocessing, and Neurovascular. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
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.
•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.
•This position will be based in Irvine, CA and may require up to 10% domestic and international travel.
Do you have a minimum of 4 years of experience in a GMP/ISO regulated environment? – REQUIRED
Do you have experience working in a quality system framework (ISO 9001 or similar)? - REQUIRED
Please select all that apply to your background and/or experience:
•A bachelor's or advanced degree in a scientific, healthcare or other technical discipline - REQUIRED
•Medical device, diagnostic and/or pharmaceutical industry experience – REQUIRED
•Proficiency with Microsoft Office applications, Adobe Acrobat, and ability to quickly and efficiently extract data is required – REQUIRED
•Project management and/or project leadership experience – ASSET
•Experience with MDRs and/or MDVs – ASSET
•Experience with failure analysis and root cause determination - ASSET
•Working knowledge of quality system requirements (QSR), ISO 13485 and Risk Management ISO 14971 - ASSET
•Failure Mode Effects and Analysis experience - ASSET
This position will be based in Irvine, CA and may require up to 15% domestic and/or international travel. Are you willing and able to meet these requirements? – REQUIRED
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