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Customer Quality Specialist


Cerenovus, Johnson & Johnson’s Neurovascular Division (CNV), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Customer Quality Specialist – Cerenovus, located in Irvine, CA.


The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.

Cerenovus, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. Cerenovus offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

With a priority focus on neurointerventional therapies, we aim to expand our portfolio in both the hemorrhagic and ischemic segments where there is a strategic fit, growth potential and significant unmet patient need. Our recent acquisitions of Pulsar Vascular and Neuravi are examples of our commitment to driving innovation and improved clinical outcomes in this area.

You, the Customer Quality Specialist, 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.


Qualifications
  • A minimum of a Bachelor’s degree is required; a concentration in a scientific, healthcare or other technical discipline is required.
  • A minimum of 2 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.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-California-Irvine
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
5017171116