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Senior Customer Quality Specialist
Requisition ID: 6388180319
Johnson & Johnson's Family of Companies is recruiting for an Senior Customer Quality Specialist to be located in Irvine, CA to support our Medical Devices business.
Johnson & Johnson Medical Device Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years.
You, the Senior 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.
- 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.
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.
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