HireDiversity

Irvine, CA, US

Product Complaint Specialist I-5953121220

Description

Advanced Sterilization Products (ASP), a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Complaint Specialist I, located in Irvine, CA.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.

The Product Complaints Specialist I will assure the receiving and processing of customer complaints are handled in an appropriate manner consistent with all laws and regulations pertaining to patient confidentiality and regulatory compliance. This applies to all products manufactured and/or distributed and serviced by Advanced Sterilization Product. The Product Complaints Specialist will receive, investigate, and close complaints for all products and ensure all QSR and department procedures requirements are maintained. Will ensure receipt, analysis and investigation of returned products, monitoring and reporting of all complaints are handled in a timely manner and consistent with all regulations. Provides expertise to enhance complaint-processing system
Review complaint files for closure and complete MDR, if required. Responsible to monitor complaint activity and alerts supervisor of potential triggers or emerging trends and will assist in generating monthly and quarterly management meeting reports. Provide complaint trend information to functional management as required and independently evaluate information and provides recommendations. Responsible for taking appropriate steps to maintain confidentiality of patient information. The Product Complaint Specialist will also assist in FDA and Notified Body inspections, write/modify departmental procedures, research and analyze complaints data for special projects, assist with implementing productivity improvements and additional duties as assigned.

Qualifications


A minimum of BS / BSN Degree (science or engineering preferred) with 1+ years of related experience and/or training in complaint/call center activities or a minimum of a High School Diploma with 3+ years experience in a complaint-handling role is required. Experience making MDR reportability decisions is preferred. Proficiency in MS Office and data entry required. Experience in a Medical device manufacturing environment or other regulated environment required. Experience with Siebel software is preferred. Excellent communication (written and verbal) skills required. The ability to effectively present information and respond to questions from internal and external customers will be required. Ability to function in a team environment and deliver on team objectives will be needed. Strong critical thinking and analytical skills required. The ability to select appropriate information management and analysis tools and to conduct analysis and interpret results will be needed.

This position is located in Irvine, California.

If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, apply to this position today!

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Primary Location:North America-United States-California-Irvine
Organization: Ethicon Inc. (6045)
Job Function: Quality Systems